ࡱ> 5@ 0Kbjbj22 (&XXc3*BBBVYYY8Y ZVH^^(^^^___Ǽɼɼɼɼɼɼ$VR>Bq__qqBB^^qB^B^ǼqǼYBB^^ p#FYz٪,0H}xXVVBBBB"B'_e2i\Km___VVdRY)^VVYSub-Working Group on Regulatory Issues For the 12th Plan (2012-17) The Terms of Reference of the Sub-Group on Regulatory Issues in the Pharmaceutical Industry for the 12th Plan 2012-17 issued vide OM No. 35022/16/2011-PI.III dated 23.5.2011 (Annex-1) are: i. To review the present status of WHO-GMP (World Health Organization Good Manufacturing Practice) certification and schedule-M compliance and suggest measures for raising the level of compliance by manufacturers of drugs and pharmaceutical products in the country. ii. To assess the adequacy and relevance of present regulatory mechanism of drug and pharmaceuticals sector and examine need for further strengthening to tackle the menace of spurious drugs etc. and examine need for an apex authority to control price, quality and supply of drugs. iii. To indicate the milestones to be achieved in the 12th Plan in the context of long term goals as per item-I of the ToR (By Planning Commission) and recommend programmes/schemes/measures that are to be initiated, continued or discontinued in the 12th Plan period and estimated fund requirement. iv. To make any other recommendations as may be appropriate for sustained growth and competitiveness of the sector. The Sub Group had the following as its members: ----- A number of other Members were co-opted as per requirement. These were: ----- The Sub Group held four meetings on 9.6.2011, 17.6.2011, 28.6.2011 and 18.7.2011. Minutes of the meetings are at Annex-II. The Sub Group meetings took into account the recommendations of the 11th Plan (Annex-III) and their implementation status. Based on these, further discussions took place on the Terms of Reference for the 12th Plan. The issues for the 12th Plan for this Sub Group broadly fall into two categories namely for domestic production and for exports. Additionally regulations also concern new drug testing regulatory requirement, nutraceuticals, veterinary and plant medicine, bio pharma drugs. Within these, the Sub Group focused on reviewing the present status of WHOGMP certification including Schedule M compliance as also to assess adequacy and relevance of present regulatory mechanism of drugs and pharmaceutical sector. It is mandated to make recommendations to tackle menace of spurious drugs etc. and to examine need for an apex authority to control price, quality and supply of drugs. Issues relating to statutory provision for incentivizing research & development of generic and new drugs were also discussed. At the outset, the Sub-Group noted that presently total production of drugs in the country is about US $ 20 billion. DoP is targeting to grow the industry to US $ 100 billion by 2020. Given the estimated contribution of 30-40% by the SME sector, the production contribution would need to increase from an estimated value of about US $ 8 Bn to US $ 40 Bn by 2020. Thus, a five-fold increase has to be made in the growth of the SME sector in the next 10 years. The SME sector is also doing contract manufacturing for large MNCs and large Indian Pharma companies. This shows the potential of the SMEs and for the growth of SME sector. The contribution of the SME sector is discussed in more details later in this document as it was important point of discussion for the Sub Group. Nevertheless it was unanimously agreed that in order to support the growth of the Pharma Industry, the role of SME sector is important alongwith with the leadership role of the large sector and so, a multi pronged strategy would be necessary particularly in the context of the regulatory framework required for enabling the growth of the Pharma sector as a whole. Issue wise the recommendations of the Sub Working Group are as below: 1. To review the present status of WHO-GMP (World Health Organisation Good Manufacturing Practice) certification and Schedule-M compliance and suggest measures for raising level of compliance by manufactures of Drugs and Pharmaceutical products in the country. 1.1 Schedule-M Compliance 1.1.1. The revised Schedule-M compliance standard was made mandatory w.e.f. 1st July, 2005. The 11th Plan discussions on this subject made efforts to obtain the correct picture as to how many units were Schedule-M compliant. The exact assessment was not possible due to lack of accurate data due to shortage of drug Inspectors with the Ministry of Health which is mandated alongwith the State Regulatory Authorities to assess the compliance levels. However, it recommended a Pharmaceuticals Technology Upgradation Fund Scheme (PTUFS) for enabling Schedule-M compliance levels of the SME Units by proposing an Interest Subsidy Scheme offering an Interest Subsidy of 5% on the loans made available to the SME Units with assistance of upto Rs.50 lac to Rs.100 lac per units (Annex-III, Recommendations of 11th Plan). The scheme was to be operational for two years. It was also proposed to give soft loan. It was estimated that out of the existing SMEs 40% may come forward to take assistance from the scheme. A fund requirement of Rs.560 crore was estimated and the scheme was to be implemented with SIDBI as the nodal financial institution. 1.1.2 The Planning Commission approved the scheme with an outlay of Rs.340 crore. Later however, the Department of Expenditure during the EFC dated 02.03.2009 for the scheme advised that the existing upgradation scheme for SSI Units (CLCSS: Credit Link Capital Subsidy Scheme) being implemented by Ministry of Micro Small and Medium Enterprises (MSME) may be tweaked to include assistance for upgradation of the SSI Pharma Units to Schedule-M standards. Based on the observation of the EFC, DoP in consultation with industry finalized list of equipments for assistance under the CLCS Scheme whereby the eligible equipments list was increased from 42 equipments to 178 equipments and machineries. Accordingly a Guideline was issued by MSME on 13.7.2009. The CLCSS had provision for giving one time capital subsidy assistance of upto Rs.25 lacs for upgradation projects of SSIs upto a total project cost of Rs. 1 crore. As per the scheme a unit had to take a loan of Rs.75 lacs for availing the capital subsidy assistance of Rs.25 lacs. 1.1.3 Following the notification DoP organized workshops in 9 large pharma cluster places Mumbai (Thane), Aurangabad, Nasik, Chennai, Ahmedabad, Hyderabad, Chandigarh, Indore and Bangalore. These meeting were organized by in partnership with Industry associations SPIC, IDMA, CIPI, FOPE etc. While the participation was encouraging, actual applications for assistance did not materialize. There was reluctance on part of the SSIs to avail loan for taking advantage of the capital subsidy as envisaged in the CLCSS. The provision for assistance by inclusion of 178 machines/equipments was announced as above only in July, 2009, that is 4 years after promulgation of the revised Schedule-M scheme by which time a number of units had either closed down or reduced their lines of production for ensuring Schedule-M compliance. Therefore, after 4 years not many units were keen to take assistance as per the revised CLCS Scheme for SSI Pharma Units. Consequently, the scheme advantage could not be rolled out. 1.1.4 Based on the above experience, now no assistance seems to be required for Schedule-M compliance achievement by SMEs. All future units are being setup with compliance to revised Schedule-M standards. 1.2 WHO-GMP Standard Compliance 1.2.1 India is a member signatory country to the WHO certification protocol on the quality of pharmaceuticals products moving in international commerce as resolve by WHA 22.5 (1969). India, being a signatory state has accepted the GMP text as an integral part of the standards for export of pharmaceuticals products. As per arrangement, WHO-GMP certification is granted by the office of the DCGI (CDSCO) and State FDAs. The certification is for two years at a time. 1.2.2 Since export of generics is to be a key strategy for growth of pharma industry in the country, hence upgradation of SMEs to WHO-GMP standards would enable them to export their products and thereby increase profitability. It is estimated that at present about 800 units are certified by CDSCO for WHO-GMP production. As there are about 10,000 plus Pharma SME Units in the country, therefore, the number of WHO-GMP standard units should be raised to at least 2000 by 2012 to enable the SME sector to increase and sustain its participation in the Pharma Industry growth process. This is also important from the point of you that increasingly the regulatory requirement are tending to become more stringent both in the country as well as internationally and therefore it is for the benefit of the small, medium and large sector. Accordingly to make a reasonable impact on the growth given the ambitious target of achieving USD 100 Bn production by 2020, it is estimated that about 1000 - 1200 units will have to be assisted for raising their manufacturing standards to WHO-GMP levels. At an average production contribution of USD 10 Mn per unit, this would mean additional contribution of about Rs.10 Bn from the above target achievement. This would require modification of the list of machineries from the existing Schedule-M requirements. It was accordingly decided that a list of machinery and equipments required for WHO-GMP manufacturing standards would be prepared formally by DCGI and communicated formally to the Department of Pharmaceuticals (DoP) for circulating to all concerned Industry Associations for their feedback before taking up the matter with the Ministry of Micro, Small & Medium Enterprises (MSME) for upgrading the list along with cost details under Credit Linked Capital Subsidy Scheme (CLCSS). This would form part of the DPR for WHO-GMP standards achievement. MSME would then accordingly include the list in the list of equipments and expenditure approved in the CLCS scheme for SSI pharma to begin with. It is estimated that upgradation to WHO-GMP standards would require project assistance of about Rs.3 crores. Accordingly, it is proposed that assistance to SSI Pharma Units under the CLCSS may be provided for project cost of upto Rs.3 crores with capital subsidy of Rs.1 crore from the current level of Rs. 25 lakhs capital subsidy on a total project cost of Rs.1 crore. Also the assistance should be dovetailed to provide soft loan interest rates by the Banks for this upgradation. Similar assistance would be provided to the medium scale enterprises who are not WHO-GMP standard but wish to achieve the level for increasing their competitiveness. On the whole this (for 1200 units at the rate of Rs.1 crore per unit) would require total financial assistance of Rs.1200 crores as subsidy. An alternative to capital subsidy can be interest subsidy scheme as earlier proposed under the PTUFS for Schedule-M compliance in t he 11th Plan with the difference being that now a similar procedure is being recommended for achieving higher standards i.e. WHO-GMP standards. It is proposed that a Detailed Project Report (DPR for WHO-GMP manufacturing standards upgradation for SMEs) may be prepared by DoP for this and submitted for approval of Planning Commission and the Department of Expenditure through the EFC process for assistance under the 12th Plan. For the medium scale enterprises DoP would finalise the scheme already pending with the Planning Commission by providing required data on the number of medium level pharma units and their status of WHO-GMP standard achievements. 1.2.3 Meanwhile, all representatives of industry associations (IDMA, SPIC, CIPI, FOPE, BDMA, FICCI, CII, ASSOCHAM) would consult their members to ascertain the status of compliance to WHO GMP and other International Standard and provide the details of at least 100 or more units of SSI and MEs each which would be requiring assistance from the Government for WHO upgradation. DoP would also issue advertisement in newspapers inviting companies to give their proposals for upgradaton and accordingly provide details for upgrading their facilities. There would be established process for checking the WHO-GMP compliance status as well as the gap required to be filled for achieving the set standard by installation of requisite plant and machinery as well as required operating process and procedures. 1.2.4 The DCGI representative has emphasized that an important component of the WHO-GMP certification was training required for putting in place standard operating procedure to ensure WHO-GMP compliance. Accordingly, it was decided that the DoP would organize workshops with the help of DCGI to educate SME units and industry workmen about WHO-GMP standards in coordination and partnership with SIDBI / Banks / SISI / DCGI / Industry Associations for this. For this, CIPI would organize workshops in appropriate locations in Northern India, IDMA in Western India, BDMA in Southern India. It was decided that in future representative of banks/ Financial Institutes along with regulatory officials will also be ensured in order to sort out problems of loan disbursement and other related problems being faced by SSI units. These workshops should be funded by DoP. A detailed Working Manual would be prepared and published for distribution to all concerns regarding achievement of WHO-GMP standard. As regards, compliance of reference standards was concerned, the Group felt that the DCGI has not been able to provide Reference Standard, for example G.S.R. 852. In this context, it has been decided that the reference standards should be specified clearly and unambiguously. For this, reference working standards, impurity standards, etc., should be worked out in consultation with the industry. 1.2.5 Further to above it is recommended that DoP should setup a full fledged International Manufacturing Standards Training Centre especially for the industry regulatory skill building as discussed above. A similar recommendation of Rs.100 crores was made in the 11th Plan but however the same could not be implemented. It is accordingly proposed to setup one national center and five regional centers at Chandigarh (at NIPER, Mohali), Hyderabad, Chennai, Ahmadabad, Mumbai and Kolkata. An amount of Rs. 60 crores should be allocated for setting up of the centers. This would meet the capital cost including land, building and equipments. As regards the operating cost, 70% would be borne by the industry and 30% by the government on a recurring basis. The operation of the center would be done in a PP mode in association with the industry association. The DPR proposed earlier would detail out the structure and management of these centers. The centers would provide training in WMO-GMP standards and other international manufacturing standards like USFDA, MHRA, TGA, EDQM etc., Training would also be provided on Indian Pharmacoepia as well as International Pharmacopeia standards required for achieving standards compliance. Some 5,000 suitably qualified working professionals in the industry would be trained as above. Professional Consultants would be hired for the purpose would also assist in developing Standard Operating Procedure (SoP) required for achieving compliance standards. 1.2.6 The Sub Group also discussed synergy strategies to address regulatory compliance even while promoting growth of the pharma industries. In this connection, Cluster based approach was discussed as an important strategy now increasingly being recognized as an effective and sustainable strategy for competitive enhancement of MSMEs. Such an approach, which leverages the geographical proximity of the enterprises on collaborating while competing principle, is participatory and cost effective. As it provides critical mass for customization of interventions, the DoP could implement Cluster Development Programme for Pharma Sector SMEs (CDP-PS) to enhance Quality, Productivity & Innovative capabilities of the SME Pharma sector in the country through better standards compliance. The Scheme would be implemented on a Public Private Partnership (PPP) format. Support from the DoP would be by the way of grant for creation of identified infrastructure and Central facilities will be set up by Special Purpose Vehicles (SPVs), formed by group of entrepreneurs from the Cluster being benefitted. Such clusters presently exist in Baddi (HP), Hardwar (Uttarakhand) and Gurgaon (Haryana) in the north, Pattancheru, Pashmalyram and Khazipalli (in A.P), Alandur and Ambattur (both in TN) in the South, Thane, Nashik, Aurangabad (all in Maharashtra), Vadodara and Ahmedabad in Gujarat in the West and Goa/Sikkim in other special areas. Therefore, such Central facilities would be set up in their clusters in the first instance. Examples include: Central Facilities Centre for quality and Govt. compliance. Central Cold Chain facilities for Pharma Products. Central Formulation and Product Development Facilities. Central Environment Treatment Plant Facilities. Other Common facilities as may be required. The GOI grant would be restricted to assistance for land, building and machineries cost. The operational cost to the extent of 70% would be met by the industry on a recurring basis. 1.2.7 The cluster development approach could also be expended further to include setting up of centers for generics development even while ensuring synergistic regulatory compliance. For this it was envisaged that formulation development center could be established which would assist the SME Pharma in particular for development of new formulations with a view to taping the vast opportunity opening up due to off patenting of a number of molecules resulting in drugs worth US $ 300 billion to lose their patent in the next five to seven years which would come under the generic domain and would so be available for manufacturing by any unit after the expiry of the patent period. In this regard it was recommended that there should be at least one National Formulation Development Centre (NFDC) set up to assist the SMEs for the development of new formulations which are the source of increasing production in the domestic and export market. India Pharma Sector can tap this opportunity only if the SME pharma sector is able to grow itself to develop this generic formulation and to produce them not only for domestic consumption but also for exports. For this, as already stated, not only there should be technological help but infrastructure facility assistance in the form of PPP model set up of at least one Regional Formulation Development Centre (RFDC) in each of the identified cluster growth areas of the pharma sector in the country. 1.2.8 The Sub Group recognized the importance and usefulness of IT for strengthening regulatory compliance in a cost effective manner. Accordingly it was recommended that a project for developing IT software may be taken up for helping the SMEs in achieving various regulatory compliances. After development, the software would be distributed by the Department to the industry free of cost. DCGI office would provide full technical guidance support for this. It was also decided that MoHFW/IPC would consider that in order to increase awareness among SME, an option of reducing the cost of Rs. 15,000 per copy by putting Pharmacopeia on the internet may be explored as is the practice for several international pharmacopeia such as USP and BP. 1.2.9 Under the Drug Price Control Order such SSI pharma units are exempted from Price Control. In this context, as the SSI units have no incentive to grow themselves into medium level in the present price control regime, a special provision needs to be made for the SSI pharma units to enable them to have higher level of investment in plant and machinery as mandatorily required for WHO-GMP Certification even while claiming SSI status. Therefore, limit of SSI categorization of pharma units should be increased from 5 crores to at least 8 crores both for DPCO incentivisation and MSME assessment. Similarly in the DPCO, the exemption from price control would be provided to Pharma Units having appropriately certified investment of upto Rs.8 crores in plant and machineries and having WHO-GMP certification. 1.2.10 Other related issues discussed in the Sub Group related to (i) Marketing Authorization for generic product approved in regulated markets, (ii) Marketing Authorization for generic product not approved in any regulated market; (iii) Clinical Trial Application for generic version of a medicine already approved in India; (iv) Clinical Trial Application for generic version of a medicine not approved in India; (v) Clinical Trial Application for a new drug having origin in India and (vi) Clinical Trial Application for a new drug having origin outside India. It was further stated that the current practice of clubbing different activities under one process should be done away with. IPA stated that approval for marketing norms is different for conducting clinical trials for generics. IPA has submitted a document to MOHFW in this regard. It was decided that a copy of the document would be forwarded to DoP. It was pointed out that marketing approval and approval of clinical trials need to be delinked. It was further stated that drugs available in the other countries but being marketed first time in India are being classified as new drug for which Clinical Trials are required to be conducted. DCGI representative stated that Drugs & Cosmetics (D&C) Act 1940 only defines drugs and new drug and generics have not been defined in the Act. There is a requirement of producing minimum 3 batches of 1 lakh tablets for conducting stability data and for ensuring consistency of quality. Further, the batch size of 1 lakh tablet though is generally fixed; it can vary depending on the product involved. DCGI representative while pointing out the need to conduct phase III clinical trials in the country as per the requirements Schedule 'Y' of D&C, Act 1940 stated that results related to stability and efficacy varies from population to population. It was decided that all related issues should be elaborated by the industry and feedback should be given to DoP. MoH & FW should nominate a representative of DoP to all Committees being set up by MoH&FW for recommending changes in this regard in future. 1.2.11 Regulations concerning Government procurement from SME sector There is a need to have a strategy for government procurement of drugs/ medicines from SME as various state governments/ Government Institutions have laid down restriction of minimum turnover of 35 to 50 crores for SME sector, for which efforts need to be made to remove such restrictions. It was also stated that 70% Government procurement amounting to Rs.7000/- crores is being done from SME units. IDMA also informed that this issue was taken up with the Competition Commission earlier. However, Commission has not taken any concrete action since all circulars and instructions were stated not to be notified. In this connection, all the industry associations representatives stated that the issue of insistence on WHO GMP compliance by the government institutions/hospitals also needs to be addressed suitably for Government. DCGI representative informed that a circular has already been issued in 2005 in this regard. It was decided that a copy would be provided by DCGI which would be circulated to all Industry Associations by DoP. It was also decided that copies of guidelines/ instructions/circulars in this regard issued by various State Governments/Institutions/Hospitals would be provided by IDMA to DoP and this issue would be discussed further by organizing a meeting of all concerned stakeholders. 1.2.12 Regulation of biosimilar drugs It is understood that the Department of Biotechnology (DBT) has drafted a set of guidelines for conducting pre-clinical trials of biosimilars. These are in the context of regulations concerning manufacture and marketing of biosimilars presently governed by the Environment Protection Act of 1970 and the Drugs & Cosmetics Act of 1940. Presently, even though biosimilars are regulated under these provisions of these Acts, there are no set of specific rules to enable speedier and unambiguous clearance for production of biosimilars. This is important in the context of the fact that biosimilars is a very strong emerging market opportunity for the country to the tune of Rs. 300 bn. The DBT needs to take into confidence the industry through DoP to enable drafting of proper guidelines for production of biosimilars in the country. 1.2.13 There is also discussion regarding formulation of a National Antibiotic Policy by incorporating a new schedule namely HX in the Drugs & Cosmetics Act so as to prevent large scale misuse of antibiotics in the country which are currently placed under Schedule H of the D&C Act. This mainly concerns prescription and retailing of antibiotics but should be done in consultation with the industry through DoP. 1.2.14 Another important issue concerns regulation for approval for fixed drug combinations. This needs to be evolved in consultation with the industry. The DTAB under the DCGI should have a representative of DoP so as to ensure that the Pharma Industry concerns are addressed in a speedy and unambiguous manner. 1.2.15 The classification of medical representatives hired by the Drug Industry as Workmen and the Labour Laws needs to be carefully examined again in the context of the nature of the job which is an important regulatory issue concerning the pharma industry sector. The industry and the DOP need to be taken on board in the context of ongoing discussions in the Ministry of Labour and in the Ministry of Health. 1.2.16 The following actions are identified to overcome the challenge relating to regulatory incentivisation of the Pharma sector in the context of R&D and also for taping the generics opportunity. Present StatusProposed Change(a)The fiscal benefit of weighted deduction for expenditure on scientific research u/s 35 (2AB) of Income Tax Act expires on 31 March 2012This should be extended for a period of at least 10 years upto 31 March 2022. It should always remain valid for 10-year period.(b)The expenses incurred on clinical trials, bio-equivalence studies, regulatory approvals and patent filings outside are not eligible for weighted reduction u/s 35(2AB). Section 35 (2 AB) should be modified to include these expenses.(c)S. 35A offers 200% weighted deduction for in-house R&D. However, with the imposition of Minimum Alternate Tax [MAT] of 20%, companies are unable to avail full benefit of weighted deduction. Though the law provides for carryover and set off, the ongoing and ever growing investment in R&D does not allow benefit of weighted deduction to R&D intensive industry. Modify MAT to allow companies to take benefit of weighted deduction of 200% for R&D. Alternatively, the amount spent for R&D should be treated as TAX CREDIT [Investment Tax Credit] and be allowed to be set off against Tax and/or MAT Payable. (d)The weighted deduction u/s 35(2AA) allowed on sponsored scientific research undertaken through an approved national laboratory, university, Indian Institute of Technology and other specified institutions was increased from 125% to 175%. The weighted deduction u/s 35(1)(ii) on contributions made to approved scientific research association, university, college or other institutions was also increased from 125% to 175%. Similarly, the weighted deduction on contributions made u/s 35(1)(iia) to a company engaged exclusively in R&D and approved by the specified authority, should also be allowed.(e)Grants and Interest Subsidy Allow grant of upto 75% for capital investment in technology development. Offer soft loans for capital investment and working capital for technology development. Ease administrative price control on products commercialized out of indigenously developed technology.(f)Exemption from Duties and Taxes: Input credit is available only if R&D equipment and raw materials are used in the same premises where excisable goods are manufactured Several companies have set up R&D centres away from their factory premises. They are not eligible to claim credit for inputs/capital goods procured for the purpose of research and development. Thus, there is a distinction between R&D units within the factory premises and outside the factory premises.The rules should be amended to allow CENVAT credit on all inputs used for R&D purposes even if they are used in a location outside the factory premises. All inputs including capital goods and equipments necessary for carrying out research and development should be fully exempted from all duties and taxes.  1.3 Schedule-L compliance The DCGI has made it mandatory for all units to be Schedule-L compliant as from August, 2011. In this context there is need to understand the applicability of Schedule L compliance for SSI Units are part of the GMP practices. As per DCGI, guidelines for GLP compliance applicable only for pre-clinical studies. In view of the divergent views expressed, it was decided the issue of compliance of Schedule L would be examined and clarification would be issued thereafter by M/o Health & FW. It is also to be examined as to what amendments need to be made in the list of 178 items/equipments currently included in the CLCSS scheme of MSME for Pharma SSI units for Schedule M compliance and modified list, if required, along with cost details and other requirements for ensuring Schedule M and L compliance would be suggested by O/o DCGI. Initially DCGI would undertake this exercise which will focus on critical items which make major contributions in production facilities especially of SSI and MEs. The industry associations would give their suggestions for modifying and upgrading the current list. Also it was decided that there is need to remove confusion and apprehension of SSI units and clarification to this effect that for units already compliant to Schedule M no further compliance for Schedule L need to be ensured, would be issued by DCGI/ MoH & FW. 2.0 Regulatory matters concerning Exports - IPR, TRIPS, Patent Linkage, Importing countries standards compliance, FTAs, Data Exclusivity and other related issues 2.1 On the issue of Regulatory matters concerning Exports - IPR, TRIPS, Patent Linkage, Importing countries standards compliance, FTAs, Data Exclusivity, etc., it was pointed out that both large and SME units are finding it difficult to cope up with the stringent demands being placed on these units especially related to Intellectual Property Rights (IPR) and other regulatory demands. In this connection it was recognized that Indian Pharma Industry consists of 50% domestic and 50% of export market and issues concerning both these segments need to be addressed separately. On account of this, for the export units, different requirements are being specified by importers in different countries, which are becoming difficult to comply with. Further, different Laboratories especially Government and Private labs are having different Standard Operating Procedures (SOPs). As a result samples being tested for export in Government/public labs are most likely to fail. In this context, there is a requirement to spread awareness and educate SME units about SOPs for testing their products. In this regard, while the Indian Pharmacopeia has prescribed testing procedures and is currently having 2000 monographs including validation of procedures which has to be followed by all manufacturers, there needs to be clear understanding on the requirements. It was accordingly recommended that DoP in partnership with MoHFW/IPC launch programmes to increase awareness among SME and country wide workshops for training SME pharma on the SOPs for testing and fulfillment of Exports requirements. Even for regulations compliance as per existing status there is need for training of the Pharma professional in a workshop mode to train them concerning compliance on existing IPR, TRIPS, Patent Linkage, Importing countries standards compliance, FTAs and Data protection provisions. This is besides the fact that contentious issues concerning these points need to be addressed in a comprehensive manner on a continued basis which the DoP needs to take up in a more proactive manner. 2.2 It was further recognized that exporting units including bulk drugs and formulations Pharma units are facing three types of non-tariff barriers related to regulatory requirements from EU. Firstly that Indian Drug Manufacturing Units exporting to EU have to ensure compliance to EDQM and have to obtain their certificate for every drug in addition to the standards for the importing country. This is acting as an additional barrier. IPA further informed that EDQM certificate is applicable for bulk drugs for 3 years and there is currently a proposal under consideration for charging 15,000 Euros for issuance of certificate per bulk drug. Secondly, in the case of bulk drugs, third party audit are being insisted upon as a result companies are being forced to divulge their intellectual property infringing on their right to protect data. Thirdly, EU is insisting on verification of pedigree of Active Pharmaceutical Ingredients in case of export of formulations. In order to address this multipronged barrier, there is a need to create synergy among various government departments/ministries viz. Department of Commerce (DoC), Pharmexcil, M/o Health & FW, DoP for formulating an integrated strategy to tackle such barriers and may include taking counter measures. The efforts by Pharmexcil in taking up the matter with DoC were discussed including the initiative to take up dialogue with the concerned embassies and MPs from EU in India. DoP needs to take up this issue in a more proactive manner with DOC etc. 2.3 As regards the requirements for IPR enforcement under various trade agreements viz. Trade Related Intellectual Property Rights (TRIPs) of WTO, World Intellectual Property Organisation (WIPO), Anti Counterfeit Trade Agreement (ACTA), etc. due to lack of clarity of the exact requirements under these agreements, exporters in India are facing problems in ensuring their compliance which is affecting their exports. Furthermore, efforts are being made by a few countries especially developed countries to define additional requirements in a sophisticated manner resulting in TRIP plus arrangement which is likely to impact Indian exports adversely in the long run. IDMA representative stated that they had already taken up the issue, and are currently observer on WIPO and had attended latest Congress in Paris. These issues need to be tackled in a comprehensive manner by joint efforts of DoP and DoC . 2.4 Another issue concerns Trans Pacific Partnership Agreement (TPPA), a new regional free trade agreement which include the United States, Australia, Peru, Vietnam and Malaysia, Japan, etc. and builds on an existing Free Trade Agreement between New Zealand, Chile, Singapore and Brunei Darussalam. Under TPPA, these countries are defining stringent conditions even for products transiting these countries which are likely to have adverse impact on Indian Pharma products. In this connection while the private industry has taken up initiatives with South American countries, namely Brazil, Argentina and Mexico etc. to address issues related to exports, however, problems remain especially with countries like Argentina. These need to be addressed emergently. In this connection, while there is a trust deficit between the industry and the government especially in the context of government signing Free Trade Agreement(s) with various countries wherein facility of zero duty is being extended there is every likelihood of creation of further problems without proper involvement of the Industry. 2.5 On the issue of data exclusively It was agreed that data exclusivity should not be insisted upon as there are 200 preparation patents are expiring in USA. While DoC has taken up issue of data exclusivity and patent linkage and draft also has been circulated by Deptt. of Industrial Policy and Planning (DIPP), there is a chapter on investment related to issue of IPR which might impact industry adversely. In this connection, while assurance has also been given by DoC/DIPP that additional conditions of IPRs would not be imposed and statements issued to the effect that India would not accept any TRIPs plus arrangement including any condition of data exclusivity there was need for to be actively involved on behalf of the industry with DoC and DIPP for a holistic view point. 2.6 It was recognized that while there is need laying a pathway for building and improving regulatory infrastructure of the country, however, the pathway should be calibrated to suit the countrys social goals and infrastructure. Utmost care should be taken to ensure that the regulatory authority is exercised with caution and after consultations with the stakeholders. Nothing should be done blindly to imitate the regulatory norms of the developed countries that may curb development of innovative processes for better yields and quality a unique strength of the Indian pharmaceutical sector. It was agreed that regulatory requirements are being modified at very fast pace which is creating problems for domestic manufacturers. Though the industry is not opposing the regulatory requirements being specified by the Government, there is need for the Government to ensure smooth transition. It was recognized that the regulatory environment is becoming more stringent day by day due to popular pressure even for domestic manufacturers in developed markets. In this context therefore, Indian pharma industry needs to assume a leadership role and effort to be supported by pro active participation of MoH&FW and DoP. 2.7 In the special context of these regulations impinging on Indian Pharmas leadership in the API sector, it was decided that in order to address these issues, details of APIs production especially in Spain, Italy, Portugal and Eastern Europe would be collected. IPA and BDMA would conduct a study, to be funded by DoP, and prepare a report on export of Indian APIs/formulation drugs to EU and details of APIs being manufactured in these countries in 4 weeks time. IDMA was asked to provide further details with regards to Paris meet. It was also agreed that there is a need to tackle these issues in organized manner wherein representatives of the industry need to be co-opted in the efforts. It was decided that a Cell would be established in IPA, to be funded by DoP, on all issues related to IPR, regulatory issues, etc. acting as barriers. IPA will respond and provides its feedback on the proposal in 3 weeks time. Also Regular and periodic meetings could be held between DoP, MOHFW, DoC and Industry to address these issues on a continued basis. 2.8 It was also decided that in order to examine issues related with possibility of adoption of Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (jointly referred to as PIC/S), two international instruments between countries and pharmaceutical inspection authorities, which provide together an active and constructive co-operation in the field of GMP. PIC/S' mission to lead the international development, implementation and maintenance of harmonised Good Manufacturing Practice (GMP) standards and quality systems of inspectorates in the field of medicinal products, is to be achieved by developing and promoting harmonised GMP standards and guidance documents; training competent authorities, in particular inspectors; assessing (and reassessing) inspectorates; and facilitating the co-operation and networking for competent authorities and international organisations. 2.9 For this, a Task Force headed by Shri V. Topa to be supported by IPA, to be funded by DoP, would prepare a road-map on all the above issues 2.1 to 2.8 and submit the details to DoP. It was also decided that report of the Task Force of Department Commerce would be examined and appropriate action would be suggested by this SWG. 2.10 2D Barcoding The Sub Group discussed in detailed regarding the Regulatory requirement regarding 2D Barcoding for export of medicines mandated by DGFT w.e.f. 1 July 2011 to prevent fake medicines. It was pointed out that Barcoding was devised as a means of Inventory Control by Supermarkets in the West as it is impossible to physically control inventory of thousands of items. That Pharma MNCs use Barcoding to prevent transfer of medicines from one country to another as their MRP varies in each country. However, since Barcodes can be replicated, hence they cannot be uncontroverted mechanism for preventing counterfeit drugs. The implementation of 2D Barcoding at tertiary level i.e. at strip level is very expensive. It is estimated that the cost for a small unit monthly cost would be around Rs.1,00,000- for barcoding. Thus for example, the cost on inks alone for a small unit producing 10,000 strips per day shall be Rs.25,000 per month which works out to be 1 paise per tablet. Additionally, there would be costs of Registration with M/s GS1, Interest on Investment on Machines, Depreciation, Rejections, Annual Maintenance Contract (AMC) which is around 10% of Machine cost, labour - especially in sorting 30% rejections. All this would add up to around 4 paise per tablet. Indian Pharma SMEs exporters are known for Affrodable Drugs the world over. Paracetamol is exported @ 16 paise per tablet. A 4 paise increase per tablet works out to be 25% increase in price - more than enough to edge out Indian SMEs from competition and loose the business to China. On the other hand while one tablet of Generic version of Viagra costs 60 paise and is exported by Indian SMEs for 70 paise the same tablet is retailed for $10 each by Pfizer under the Brand Name of Viagra in countries where Patent is applicable. It should be noted that while MNCs who export high priced patented drugs have no such problem, the SME sector would be handicapped by avoidable expenditure on extra regulatory compliance. An important issue in the connection relates to preparation of art works. Many importing customers send their artworks for labels and packings as per norms of importing country. All such orders would be cancelled or material rejected. The Barcodes have no use when Non- branded drugs for Hospitals in foreign countries are exported as they are never counterfeited like expensive brands of MNCs. A strip of 10 tablets of Paracetamol is exported for Rs.1.50 each. There is simply no motivation as it will be like counterfeiting One Rupee coins. Barcoding is impossible when labels of medicines are too small like Tetanus Toxoid and Zentel size 20mmx25mm. Hundreds of Small consignments valued between US$ 5000-10,000 each are exported by Indian SMEs each day. Each consignment consists of several items. All Such exports shall cease with one stroke in view of the fact that Barcoding renders them unviable - which seems one of the real motives. other pitfalls of Barcoding relate to the fact that Barcode Machine Suppliers have opined that rejections shall be a minimum of 30%. So far they have been unable to perfect the machines for better results. It means a lot of time and money will go into sorting out good and bad strips, which could easily result in delays and hence cancellation of orders. As per DOC, only one company namely M/s GS1 has been appointed as the sole Barcode provider by Government. SMEs will have to source their Barcodes and accessories like Inks etc, from them. It is well established that free 2D Barcodes available on the Internet. With tens of thousands of brands this would be unfair practice to benefit GS1 company In this context it is worthwhile to examine conditions like stipulation of 2D Barcoding only if the importing country mandates a specific requirement, then exporter can adhere to the same. The word importing country should be substituted by Importer. Based on the above, the Sub Group was of the recommendation t hat the matter needs to be discussed at length with DOC for acceptable resolution. It has to be understood that in the past, MNCs have repeatedly tried to browbeat India medicine exports. High quality Affordable Generics exported by Indian SMEs have been categorized as counterfeits in the West and seized at Transit Ports in Europe even when neither the producing country (India) nor the importing country in Latin America had Patents on the medicine. Also Counterfeit issues have been equated with fake and spurious drugs (a public health issue). CDSCO had mooted amendment of Definition of Spurious Drugs in World Health Assembly based on IMPACT proposal. Thus while Barcoding is being portrayed as a step towards increasing Export, in real terms it makes exports cumbersome and impossible from SMEs. Export prices shall increase and lead time for shipment shall increase which deprives Indian SMEs of competitiveness in International market. This will either enable China or MNCs to take over. The matter needs to be resolved quickly. In any case, since bar coding would be an important Regulatory requirement in the times to come, therefore, it was recommended that an allocation of Rs. 100 crores may be made for assisting SMEs to enable them to install and establish 2-D barcoding technology for the 12th Plan. A DPR would be prepared by IDMA and SPIC which would be funded by DoP for submission to the Planning Commission. 3. To examine the need for further strengthening to tackle the menace of spurious drugs, etc., and examine the need for an Apex Authority to control price, quality and supply of drugs. 3.1 It was noted that in the Eleventh Plan recommendations, a proposal for National Authority for Drug and Therapeutics (NADT) but no clarity had emerged for addressing issues related to pricing, quality and supply of drugs in holistic manner. NPPA is handling issues relating to pricing and DCGI is handling issues related to quality of drugs including Good Distributing Practices (GDP), there is currently no authority for ensuring supply of sufficient good quality drugs. There is a perceived need of industry for setting up of a NADT addressing all these issues in a single window mode. During the course of discussions, in the Twelfth Plan Sub-Working Group Two Industry associations namely OPPI and IDMA supported the proposal of having a single window system for addressing these three issues. It was pointed out by some other Associations like IPA that pricing and regulatory issues should not be part of one authority/body under any single ministry of Government of India. It was further informed that a bill of M/o H & FW for setting up a CDA dealing only with regulatory issues without addressing the issues related to pricing is pending in Parliament by taking away some powers from the State governments. This bill was sent to Rajya Sabha in 2009. In this context, it was decided that a copy of the proposal of DoP for National Authority for Drugs and Therapeutics (NADT) needs to be examined in further detail outside the Twelfth Plan Sub-Working Group discussions in a more comprehensive and focused manner. 3.2 As regards, the issue of tackling of spurious drugs menace, it was agreed that this is an exclusive subject of the Ministry of Health and hence DoP may not included in the Twelfth Plan Working Group discussions as part of subject to be dealt with in DoP. 4.0 To indicate the milestones to be achieved in the 12th Plan in the context of long term goals as per Item-I of the ToR and recommend programmes/schemes/measures that are to be initiated, continued or discontinued in the 12th Plan period and estimated fund requirement 4.1 At the outset the Sub Group discussed in depth regarding the availability of credible data on the pharma SMEs is very important. This issue was also highlighted in the 11th Plan discussions wherein it was estimated that as per 3rd All India Census of Registered SSI Units, conducted by the then Ministry of Small Scale Industry, there were 6090 SSI Units in 2001-02.. The compliance position in respect of them was stated as below: 1672 Schedule-M GMP Compliance 1797 in the process of establishing Schedule-M GMP Compliance 370 units not in a position to comply GMP norms 337 units have surrendered their licences for manufacture of drugs The present position of data needs to be examined in the context of the available data base of 350 companies from Centre for Monitoring Indian Economy (CMIE). It provides very useful information from the published annual accounts of companies. The table below from this data base presents domestic and export sales of Formulations and APIs (at the first point) for the 15-year period ended March 2010: Domestic and Export Sales (Rs. crores) YearExports Growth %DomesticGrowth %TotalGrowth %Mar 19951,701.130.0010,645.580.0012,346.710Mar 19962,498.5246.8712,676.8619.0815,175.3822.91Mar 19972,991.4819.7313,987.6310.3416,979.1111.89Mar 19983,396.1213.5315,436.7410.3618,832.8610.92Mar 19993,923.6215.5317,998.7316.6021,922.3516.40Mar 20004,801.4622.3720,590.2314.4025,391.6915.83Mar 20015,654.3717.7621,540.814.6227,195.187.10Mar 20027,385.9530.6223,315.838.2430,701.7812.89Mar 20039,809.3132.8125,911.2211.1335,720.5316.35Mar 200412,466.1227.0829,642.5414.4042,108.6617.88Mar 200514,385.1615.3931,435.526.0545,820.688.82Mar 200616,724.3316.2637,283.5418.6054,007.8717.87Mar 200722,736.9535.9542,247.1413.3164,984.0920.32Mar 200827,155.5319.4349,087.7916.1976,243.3217.33Mar 200933,412.4523.0454,106.8910.2287,519.3414.79Mar 201036,683.349.7959,828.9310.5896,512.2710.28 Source: CMIE (As of 9 June 2011) As may be seen from the above table, the domestic sale has doubled every five years. For the 15-year period (1995-2010), the domestic sale has grown at compound annual growth rate (CAGR) of 12 per cent, whereas exports have grown faster at CAGR of 22 per cent. The CAGRs, measured by three five-year periods, viz. 1995-2000, 2000-2005 and 2005-2010, are indicative of the growth trends: CAGRs for Three Five-year Periods PeriodExports %Domestic %Total %1995-20002314162000-200524 9132005-2010201415 The deceleration in the CAGR for exports during 2005-10 could be due to global melt down in 2008-09 and rising non tariff barriers by the developed countries. The slow down during 2000-05 in domestic sales could perhaps be attributed to greater focus on the global markets. The second data base is IMS Health data. It is based on a sample of 450 companies, provides trade and institutional sales of formulations in the domestic market. Its data for the five-year period ended March 2010 is given below: Indian Pharmaceutical Market Year Trade Sales (SSA)Institutional Sales (HSA)Total Sales (SSA + HSA)Value Growth %Mar 200624437.21921.226358.415Mar 200727955.62276.930232.514Mar 200832108.82532.234641.015Mar 200935367.52949.838317.310Mar 201041700.74035.945736.618 Source: IMS Health MAR MAT 2010 The data reflects domestic sales value of formulations only. It captures sales at the second point from Stockists to Retailers and Hospitals separately. It does not capture tender or direct sales by companies to hospitals. As may be seen from the above table, the domestic formulation sale has grown at CAGR of 15 per cent in the four-year period (2006-10) from Rs 26,358cr to Rs 45,737cr. It is noteworthy that the last 200 companies in IMS Health data base contributed only Rs 114cr or 0.25 per cent of the total sales value of Rs 45,737cr in 2009-10. This is indicative of the direct contribution of the small scale sector to the total pharmaceutical direct sales. The small scale sector needs careful consideration and validation of its contribution from the sales contribution point of view so as to properly assess its role in shaping the future growth of the pharmaceutical sector. Going forward, the growth will accelerate further. The patent expiries, pressure on the developed country governments to contain their healthcare expenditure and readiness of the domestic companies will drive exports. On the domestic front, rising income, improved health infrastructure, rise in the prevalence and treatment of chronic diseases, high prices of patented products and greater market penetration will accelerate the growth. Projected Growth of Pharmaceutical Sector YearExportDomesticTotalRs 000 crGrowth %Rs 000 crGrowth %Rs 000 crGrowth %Base Year (2009-10)*36,6839.7959,82910.5896,51210(11th Plan) 2011-12 51,07818%76,39014%127,46716(12th Plan) 2016-17 130,30221%157,69016%287,99218Target Year (2019-20)232,74622%248,25917%481,00519*CMIE Data Base Source: IPA It may however be noted that these are very challenging targets. Role of Public Sector: The Public Sector, which played key role in the growth of the domestic industry, has become unviable. It would be a herculean task to revive them in todays competitive environment without protectionist policies. At best, it can become a catalyst for indigenous production of APIs and intermediates from the basic stage for supporting the domestic bulk drug industry and address strategic goal of reducing reliance on the third country thereby ensuring medicine security and growth of domestic industry. Role of Medium & Large Domestic Companies The medium and large domestic companies have been the drivers of growth, contributing 75% of direct and indirect domestic sales and over 90% of direct and indirect exports. Besides sales, other indicators that bring out contribution of the medium and large domestic companies are gross fixed assets formation, increase in wages and R&D spend. The export of top 50 companies for the year 2009-10 reveal that pharmaceutical industrys foray in the global market is driven mainly by the domestic companies (Annex B). These top 50 exporters accounted for 76% of total exports of Rs 36,683cr in 2009-10. It is noteworthy that only two foreign companies feature in this list contributing less than 2% of the total pharmaceutical exports. The annual increase in the gross fixed assets of domestic and foreign companies is given in Table below. Gross Fixed Assets and Annual Increase YearDomestic CompaniesForeign CompaniesGross Fixed Assets Rs CrAddition For the Year Rs CrGross Fixed Assets Rs CrAddition For the Year Rs CrMar 19954,64709270Mar 19966,3881,7411,085158Mar 19977,8031,4151,202117Mar 19989,5521,7501,308105Mar 199910,7031,1501,453145Mar 200012,2711,5681,50451Mar 200113,0838121,52420Mar 200214,7331,6501,499-25Mar 200317,4552,7221,729230Mar 200420,7133,2581,966237Mar 200525,6394,9252,05488Mar 200631,0615,4232,254200Mar 200736,5035,4422,522268Mar 200843,8077,3042,910388Mar 200951,9468,1383,454544Mar 201058,6586,7123,949496Total Increase in 15 Years54,0103,022 Source: CMIE This 15-year period is hall mark of Indias move to market economy and liberalization of trade and investment policies. India signed TRIPS Agreement in 1994 signaling reintroduction of product patent from 1995 and allowed 100% foreign equity through automatic route in the pharmaceutical sector from 2001. Notwithstanding these policy changes, the foreign companies seems to have done little to increase their investment in the manufacturing sector, as may be seen from the above table. The foreign companies invested Rs 3,022cr only in the fixed assets as compared to Rs 54,010cr by the domestic companies between 1995-96 and 2009-10. Wages and employment is another indicator of the contribution of the domestic companies. According to CMIE data base, the wage bill of the domestic companies reported more than twelve-fold increase over 15-year period from Rs 664cr in 1994-95 to Rs 8,172cr in 2009-10. On the other hand, the wage bill of foreign companies reported only a little over three-fold increase from Rs 350cr in 1994-95 to Rs 1,215cr in 2009-10. It is thus evident that the maximum employment is generated by the large and medium domestic companies. The employment data for the pharmaceutical sector from the Annual Survey of Industries (ASI) is given below: Employment Data for Pharmaceutical Sector Year No of EmployeesMar 19951,81,497Mar 19962,04,609Mar 19972,11,614Mar 19981,89,295Mar 19992,13,999Mar 20002,43,410Mar 20012,33,704Mar 20022,26,416Mar 20032,23,556Mar 20042,40,791Mar 20052,65,396Mar 20062,90,021Mar 20073,36,211Mar 20083,53,692 Source: Annual Survey of Industries Ministry of Statistics & Programme Implementation It may however be noted that the drugs and pharmaceutical is not a very labour intensive industry compared to textiles, software and automobiles. In the above context, the 4th Census of the MSME Units done by MSME is important. The initial assessment by DDG, Department of C&PC was of 10563 units, the details of which were published in a Directory in 2008-09. Later, this data was sought to be validated by MSME and the work was also given to expert agency ICRA. This work is still in progress and data is being collected from State Governments regarding SSI and Medium Enterprises separately along with the status of WHO GMP Compliant units. In this context, it was decided that all Industry Associations, DoP, MoHFW, Pharmexcil and MSME would team together to prepare reliable comprehensive data on SME pharma units. To begin with details of new SSI units set up since 1st April, 2008 would be collected by DCGI through State Drug Controller and provided to the Department in three weeks time. Also Pharmexcil would provide data wherever required. For this DoP should fund a study/ survey to be conducted by Industry Associations / other institutions to ascertain details of units manufacturing bulk drugs and formulations. In this regard it was also decided that CIPI will collect requisite details from Northern region, IDMA from the Western region and BDMA from the Southern region and provide the details to the department on priority basis. CIPI will also provide details of units located in excise-free area to DoP after collecting requisite details from their member units. In any case, the Group while assessing the action plan for the growth of SME sector, uniformly agreed that presently the total production of drugs in the country is about US $ 20 billion. DoP is targeting to grow the industry to US $ 100 billion by 2020. The SME sector is also doing contract manufacturing for large MNCs and large Indian Pharma companies. This shows the potential of the SMEs and accordingly DoP is targeting that the SME Pharma should grow to a size of at least US $ 40 billion by 2020. Thus, a five-fold increase has to be made in the growth of the SME sector in the next 10 years. In this context, the milestones to be achieved for the 12th Plan could be as follows: Upgradation to WHO-GMP standards of 1200 SME units by 2017 at the rate of 300 units per annum at the cost of Rs. 1200 crores of subsidy either as one time capital subsidy or interest-based subsidy Upgradation to US FDA/EDQM/TGA and other International Standards of 250 units by 2017 at the rate of 50 units per annum at the cost of Rs. 2 crores per unit and a total cost of Rs. 500 crores. Training of 5000 Working Professionals in WHO-GMP and other International Standards GMP requirements by 2017 at the rate of 1000 professionals per annum at a cost of Rs. 100 crores. Setting up of one National and five Regional manufacturing standards training centres at the total cost of Rs. 60 crores. Setting up of one National and five Regional formulation development and training centres as per International Standards at a cost of Rs. 100 crores. Establishment and upgradation of 10 Pharma Growth Clusters by 2017 at the rate of 2 per year with a per cluster cost of Rs. 50 crores and a total cost of Rs. 500 crores. Total requirement of all allocations being Rs. 2460 crores. As regards deletion/modification of existing schemes is concerned, there are no schemes in the above areas being presently implemented by DoP. The CLCS Scheme being implemented by MSME would need to be modified for SSI Pharma units with appropriate budgetary allocations. It was clearly recommended by the Sub Group that the task of the Department of Pharmaceutical (DoP), Ministry of Chemicals & Fertilizers is to catalyze and encourage quality, productivity and innovation in pharmaceutical sector and to enable the Indian pharmaceutical industry to play a leading role in a competitive global market. For this, world class quality manufacturing facilities with high level of productivity with innovative capabilities are required. The recommendations of the Sub-Group as above are expected to catalyse this process if they are implemented in a time bound and purposeful manner. -----------------------------------------------  Small and Medium Sector is defined as per the MSME Act 2006 wherein a small scale unit is defined as that having investment in plant & machinery of Rs.25 lakhs to 5 crores. The medium enterprise is defined as having investment in plant and machinery between Rs.5 crores to Rs.10 crores.  About USD 46.5 Bn.  About USD 53.5 Bn  About USD 100 Bn.     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