HOUSE COMMITTEE INDIA VISIT TO ASSESS IMPROVEMENTS NEEDED

UNCLAS SECTION 01 OF 07 NEW DELHI 004586 SIPDIS HHS FOR OGHA STEIGER/VALDEZ/HICKEY CDC FOR BLOUNT/PETROSKY NIH FOR GLASS/MAMPILLY OES/PCI FOR STEWART OES/IHA FOR SINGER GENEVA FOR WHO FDA FOR LUMPKIN/WELCH SENSITIVE SIPDIS E.O. 12958: N/A TAGS: TBIO SENV AMED CASC KSCA IN SUBJECT: HOUSE COMMITTEE INDIA VISIT TO ASSESS IMPROVEMENTS NEEDED IN THE FOREIGN DRUG INSPECTION PROGRAM REF: (A) Beijing 6252 (B) New Delhi 2169 NEW DELHI 00004586 001.2 OF 007 ¶1. (U) Summary: The Congressional House Committee on Energy and Commerce staff delegation (Staffdel) visited India September 8-15, ¶2007. The Staffdel accompanied a FDA team that was in India for inspection of a pharmaceutical company in Himachal Pradesh. The purpose of their visit was to examine a variety of regulatory, trade, and public health issues related to the safety of pharmaceutical products sold to the US and consumed by the US citizens. This cable outlines the key issues such as, the drug regulatory framework in India, the strengths and challenges perspective from both the Indian Government regarding drug inspection issues, and feasibility of the U.S. Food and Drug Administration (FDA) presence in India. End Summary. Growing Presence of Indian Manufactured Drugs in the US Market - Calls for Tighter Quality Control Regulations -------------- -------------- ¶2. (U) With the increase in Indian manufactured drugs supplied to the U.S. there is a need for more stringent regulations to ensure drug quality. India has the largest number of FDA-approved manufacturing facilities outside the US and is one of the leading suppliers of low-cost generic drugs. Recent press reports have raised doubts on the quality and safety of some products and state that the two Asian giants, China and India, account for a significant amount of USD (42 billion) imports to the U.S., particularly of active pharmaceutical ingredients (APIs). According to the Federation of Indian Chambers of Commerce and Industry (FICCI),a leading industry association, out of the 15,000 - 20,000 drug manufacturers in India about 5,000 follow the Good Manufacturing Practices (GMP) norms laid down by the World Health Organization (WHO). All Indian drug manufacturers cater to the domestic market, with about 150-200 of these who cater to the export market. ¶3. (U) According to a recent report of the Washington Post, presently, with India accounting for 20 percent of FDA generic drug approvals in 2006, it is the fourth largest producer of drugs by volume, currently sources 350 types of anti-depressants, antibiotics and cardiovascular drugs on the U.S. market, and about one in four applications for market authorization in the U.S. is from an Indian company. Low Count of FDA Inspections in India Compared to Domestic Checks -------------- -------------- ¶4. (U) Presently, FDA inspections of foreign facilities occur at a far less frequency, at once every eight years compared to the 2-year NEW DELHI 00004586 002.2 OF 007 interval required for domestic manufacturers. The rise of India as a global supplier of low-cost generics and over-the-counter (OTC) drugs increases doubt of the quality and safety of Indian pharmaceutical products. The Washington Post has put the number of inspections carried out by the FDA in India in 2006 at 32, in comparison to 1,222 quality assurance inspections carried out in the U.S. in the same year. ¶5. (U) U.S. FDA's key role is to ensure the safety of drugs and their imports to promote public health. FDA's strong safety record sets the world's gold standard for drug approval and safety. The strengthening of science based tools to augment and support the drug safety system at all stages of the product life-cycle, from pre-market testing and development through post-market surveillance and risk management. Against this Backdrop - Staffdel Visits India -------------- ¶6. (U) The House Committee on Energy and Commerce Staffdel led by Mr. Chris Knauer, Senior Investigator visited Chandigarh and New Delhi from September 8-15, 2007. The Staffdel included Dr. Paul Jung, Department of Health and Human Services, Mr. Peter Spencer, Professional Staff Member, and Rear Admiral Ms. Brenda Holman, Office of Regulatory Affairs, FDA. The Staffdel visited a pharmaceutical manufacturing facility in Chandigarh from September 8-12 to follow FDA inspectors on a site visit. In New Delhi from September 12-15, the delegation met with GOI officials, leadership of the Pharma industry, and visited two Indian and two multinational pharmaceutical drug and vaccine manufacturing companies. House Committee Staff On-Site with FDA Inspectors -------------- -------------- ¶7. (U) The Congressional Staffdel from the House Committee on Energy and Commerce visited one pharmaceutical plant in Himachal Pradesh and accompanied an FDA team that was making regular pre-approval inspections of the manufacturing facility that intend to produce and supply products to the U.S. market. The Staffdel prior to their visit to India also accompanied the FDA team to pharmaceutical plants in China (See Reftel A.) ¶8. (U) The FDA team inspected Glenmark, a private pharmaceutical company in Baddi, Himachal Pradesh, which produces API's, dosage forms, new chemical entity research, new drug delivery system (NDDS) and biotech products. The list of products from the Baddi plant of Glenmark for the U.S. market for which the list of Abbreviated New Drug Application (ANDA) is filed are Mometasone furoate cream USP 0.1%, Mometasone furoate ointment USP 0.1%, Betamethasone dipropionate augmented cream 0.05%, and Alclometasone dipropionate NEW DELHI 00004586 003.2 OF 007 cream USP 0.05%. The plant manufacturing capacity is 280 million units of tablets, 15 million units of liquid and 12 million units of ointment on a per shift per year basis. ¶9. (U) The Baddi plant has 214 employees, with 37 dedicated to quality control, 30 dedicated to quality assurance, 35 to production, and 72 technicians and operators. Problem of Counterfeit Drugs in India -------------- ¶10. (U) During the meeting with the Drug Controller General of India (DCGI) officials, the question was raised about Indian media reports of spurious drugs. The officials stated that the press was too critical and the situation on the ground was not that alarming. The DCGI plans to evaluate counterfeit in the market with a sampling of 50,000 products. DCGI officials stated that "India is concerned about an undeserved negative image of poor quality Indian drugs in the international community and is working with the WHO's International Medical Product Anti-Counterfeiting Task Force (IMPACT) to study the problem of global counterfeits". ¶11. (U) Plea from Indian officials and Industry leaders is to push regulatory infrastructure to global standards and to ensure that drugs manufactured in India are of consistent quality on a continuous basis and to adopt a "creditable" system for quality drugs and introduce the "surprise element" in inspections. ¶12. (U) Indian media reports that 35 percent of drugs manufactured are spurious, whereas the expert committee headed by the former Council of Scientific and Industrial Research Director General R. A. Mashelkar who relied on about 40,000 samples showed that less than 10 percent of the drugs in the market are substandard and less than 1 percent are spurious. (Note: The truth appears to lie somewhere in between. End Note.) According to media reports, Head of the Organization of Pharmaceutical Producers of India, Ranjit Shahani, who stated that even assuming there is only one batch of one counterfeit product in the market, several lives could be lost in a day that could add up to one jumbo jet. Health Minister Dr. Anbumoni Ramadoss believes that effective management requires change in regulatory mechanisms, change in legal and penal mechanisms, and capacity building at both State and Central levels. The GOI's bill to create an independent Central Drug Authority of India (CDAI) along the lines of the FDA is now before a standing committee that will make recommendations in about three months (See Reftel B). ¶13. (U) FICCI invited fifteen industry leaders to meet with the Staffdel and exchange views on September 14, 2007. Indian Pharmaceutical Alliance (IPA) Secretary General Mr. D.G. Shah informed the Staffdel that in India the IPA is running an NEW DELHI 00004586 004.2 OF 007 anti-counterfeiting program, by which at least two raids a month are conducted on counterfeit drug manufacturers. The target is manufacturers rather than retailers. This, according to Shah has yielded results by sales of authentic drug manufacturers increasing by a noticeable percentage in those areas. Call by Industry for FDA to Set Base in India -------------- ¶14. (U) The Staffdel heard requests/pleas from industry for establishing an FDA presence in India, so that Pharma companies can be inspected more frequently and can interact with DCGI and industry on a frequent basis. Industry leaders stated that since India has the highest number of FDA approved plants next to the US; this will also ensure that the manufacturers are careful and comply with stipulated norms of the FDA. The generic companies are concerned about their image and quality standards since the cost of failure is far more than the cost of compliance. ¶15. (U) Three main points that emerged from the discussion is to establish an FDA presence in India, enhance capacity building partnerships, and support India to improve the quality of its regulatory infrastructure as per global standards which will ensure consistent quality on a regular basis. Suggestions received from the FICCI roundtable include: - FDA stations staff in India - FDA could assist in revamping DCGI's office - India sends staff to US for training and joint workshops - Train the trainers program; where by Indian inspectors accompany the USFDA inspectors during field visits in India - Retired staff from FDA would come to India to provide training - FDA shares "SOP" (Standard operating procedures) with the DCGI. ¶16. (U) The Staffdel suggested that FICCI should conceptualize a proposal for the possible areas of collaboration between FDA, DCGI, FICCI and IPA with a meeting between all parties to move forward. FICCI assured the Staffdel that they would work on a white paper for drug inspection issues. DCGI Officials Call for Harmonization with FDA -------------- - ¶17. (U) DCGI officials required at least 1300 inspectors to carry out drug regulation inspections and presently have about 800. One problem faced is that inspectors report to the State and Central Government on most issues other than vaccines and blood products. Also, licensing to factories and distribution is not Central government but a State government jurisdiction. The officials were keen to update pharmacopeia and pharmocovigilance and were of the desire that the interaction presently is not enough. DCGI is also NEW DELHI 00004586 005.2 OF 007 keen to operate joint inspections with FDA and for greater harmonization with the SOP's of the FDA. They also would like greater frequency of training programs, create a joint training environment and operate joint workshops, and travel of DCGI staff to FDA to train and exchange views on drug regulation. Indian industry is also keen to establish and reach mutual recognition agreements and would like to exchange and share FDA's SOP's so as not to reinvent the wheel. Perspective - View from U.S. Multinationals in India -------------- -------------- ¶18. (U) The Staffdel visited two U.S. multinational drug companies who presented their view on the state of affairs of drug regulation in India. The primary problem felt is that with drug regulation being a State issue there are some that perform and some that do not. In their view, the State drug regulatory authorities at Mumbai and Hyderabad are OK but lacunae exists in other States where the local drug administration officials are not trained and there is a lot to be accomplished in the area of adverse drug reaction and vaccine regulation. Some industries do take on training programs through workshops and industry believes that joint training programs with industry for drug officials could be beneficial, however require pooled resources. Industry Perspective - Other Views -------------- ¶19. (U) Staffdel and Mission staff visited Sanofi-Pasteur, a leading global vaccine manufacturer, and an Indian vaccine manufacturer, Panacea. These bio-pharmaceutical companies stated that there is greater professionalism in the DCGI's office with shorter timelines for approval. That said, the company officials cited that the biggest hurdle faced is regulation on biologicals and vaccines with the biotechnology sector on the upswing in India. (Comment: The shorter timelines for approvals from the DCGI's office could imply that there is no one to evaluate vaccine filings with the experts on pharmaceuticals also doubling up as experts on vaccine/biologicals filings. End Comment.) ¶20. (SBU) The senior officials of Ranbaxy, a leading Indian drug manufacturer stated that the DCGI is a weak agency and there is need for training and capacity building of DCGI officials, and the need for an FDA presence in India. FDA Presence in India - Way Forward -------------- ¶21. (SBU) Health Attache proposed to the Staffdel that having FSN Scientific Advisor dedicated to FDA work in the Health Attach's NEW DELHI 00004586 006.2 OF 007 office could be an option. The Staffdel appreciated the proposal. This FSN Advisor would be FDA's "eyes and ears" on ground and could travel with the inspectors on inspections of FDA's choice. The FSN Advisor could also visit plants and do any pre-inspection work for FDA inspectors. The FSN Advisor could also gather information on "companies of interest" for FDA in drug, food, devise and other areas. The FSN Advisor could also organize workshops for DCGI-FDA interests. ¶22. (SBU) In response to a question about funding options and mechanisms available, Health Attache indicated that the HHS and HHS agencies do not have legislative authority, like USAID's Limited Scope Grant Agreement (LSGA),for funding Indian agencies/entities. The Staffdel took note of the need for HHS to have the authority to use LSGA for international work. The Staffdel mentioned that HHS needs this authority to fight diseases such as AI and engage with Indian government agencies and institutions for U.S.-India collaborations. FDA Office in India - Better Regulate Emerging Pharma Market - Key Benefits to U.S. and India -------------- -------------- ¶23. (U) The Staffdel felt that "FDA presence in India" as desired by the Indian officials and Indian drug industry representatives would help assist FDA better regulate the emerging pharmaceutical market with key benefits to both countries. Further Updates -------------- ¶24. (SBU) The FICCI interaction of September 14 had mooted the idea of creating a consultative group with the Health Ministry. FICCI has informally cleared this with Ministry of Health (MOH) Secretary Naresh Dayal, who has responded to this request positively. FICCI Adviser V.K. Topa has requested Health Attach's assistance in developing the working group and has also requested suggestions from the U.S. FDA. Health Attach will discuss this with the Department of Health and Human Services (DHHS) and FDA staff during his forthcoming visit to the U.S. ¶25. (SBU) Health Attach, about eight months ago, suggested to Health Minister Ramadoss that he appoint a technical expert to guide the CDAI, such as the Indian Council of Medical Research (ICMR) Director General Dr. N.K. Ganguly. The Health Minister has confirmed that the Secretary of the newly created Department of Health Research (DHR) and Director General of ICMR, Dr. N.K. Ganguly has been named as a co-chair of a committee to guide the establishment of the CDAI. This gives clear indication that Mission suggestions are being listened to and implemented. A formal NEW DELHI 00004586 007.2 OF 007 announcement of this appointment will be made in 2-3 weeks by the Ministry of Health and Family Welfare. ¶26. (U) This cable was cleared by Chris Knauer and Paul Jung. MULFORD