Whenever a new drug is innovated by a company or an individual researcher, the drug has to go through a series of mandatory procedures before it is actually available over the counter in the pharmacies. In India, the entire responsibility of a particular drug approval is vested upon Central Drugs Standard Control Organization (CDSCO).
The approval of a new drug involves a two phase process preceded by non clinical (laboratory tests) to ensure the effectiveness and the safety issues concerned with the drug. This is followed by the two stage process. The first phase includes actual clinical tests where the new drug is submitted for approval (NDA- New Drug Approval). This also includes the identification and analysis of new chemicals involved (if any), (NCE: New Chemical Entities, involved in reviewing the chemicals concerning the new drug). The specialized and the competent authorities involved consider the application for clinical trial of the new drug. The clinical tests are conducted then (Phase I to Phase IV). This is the lengthiest and the most important part of a drug approval process because it determines everything about the concerned drug starting from side effects to optimal doses in human beings. When the clinical tests are complete and the results are positive, the drug is considered ‘reviewed’. Marketing involves a separate application to the marketing authorities who approves and decides the marketing and post marketing strategies provided the drug is found to be positively reviewed. This is the second phase.
Rampant corruptions in the drug approval process of India
India is a fast developing nation and the third largest economy of Asia but fact remains India is a third world country and corruption and bribery has penetrated every layer of this country. The drug approval process, therefore, is no exception. The Government which had so far maintained a laid back attitude regarding the deep flaws in the drug approval process of our country, has suddenly for some reason been jolted into action. A parliamentary committee had been formed with investigative and legal powers to look into the issues concerning the drug approval procedure. The results of the investigations of the said committee were appalling. Drug Controller General of India (DCGI), the head of CDSCO, had been accused with sufficient evidence of approving one new drug every month on an average. The approved drugs were not backed by the mandatory clinical trial reports which makes the actions of DCGI a criminal offense. Even seeking expert medical advice while approving the said drugs, was considered useless. The main villain is of course CDSCO and the parliamentary committee has formally requested the Health Ministry for the complete disempowerment of CDSCO regarding any drug approval procedure.
The actions of CDSCO were under the close observations of the parliamentary committee for at least eighteen months. As per the report of the committee, “Most of the ills besetting the drug regulation in India are mainly due to the skewed priorities of CDSCO. For decades it has been according primacy to the propagation and facilitation of the drug industry.” Irrefutable evidence had been unearthed to prove the cartelization of medical experts, drug companies and CDSCO personnel, as evident from the conclusion of the parliamentary report, “There is adequate documentary evidence to show that (expert) opinions are written by invisible hands of drug manufacturers and the experts merely oblige by putting their signatures.
Some concrete evidences unearthed by the parliamentary committee
Forty two drugs were selected by the investigators from the market and approval papers were demanded for the concerned drugs from the DCGI and the Health Ministry. Of these 42 drugs under scrutiny of the committee, 11 drugs never saw the Phase III clinical tests, (which ensure the effectiveness and the safety factor of the drugs including side effects). From this point onwards the findings of the committee are even more fascinating, further highlighting the corruptions involved in the drug approval process of CDSCO. Between January 2008 and October 2010, CDSCO had approved 33 new drugs that never passed any clinical tests. These disputed drugs include Colistimethate and Pirfenidone (from Cipla Ltd.), Aliskiren (from Novartis Chemicals) and Ambrisentan (from Glaxo Smithkline Ltd.). 25 other drugs were also approved by CDSCO during this period that did not have any endorsement of medical experts. The next example is perhaps the height of CDSCO’s corruption level. Four drugs, Everolimus ( from Novartis Chemicals), Buclizine (from UCB Biosciences Inc), Pemetrixid (from Eli Lilly and Co.) and a ‘fixed dose combination’ of Pregabalin (from Theon Pharmaceuticals) were actually approved by the “non –medical staff” of CDSCO that never saw any clinical test or the opinion of a medical expert.
13 other drugs were also approved by CDSCO that are banned in developed countries. While the alleged companies deftly continue to avoid queries, Sanjay Jaisawal, a member of the parliamentary committee commented, “We will give the Health Ministry time to take action on officials and the pharmaceutical companies involved”.
Remedies being adopted by the Health Ministry
A number of pharmaceutical companies are now facing the threat of permanently losing their manufacturing license for certain drugs. These include the Belgium based company UCB Biosciences Inc for Buclizine (which ironically is banned in Belgium but being sold in India), Novartis Chemicals for marketing Letrozole, as a female fertility drug (which in fact is an anti-cancer drug) and Denmark based company Lundbeck for selling the anti depressant Deanxit (that was approved without the mandatory paperwork and banned in most developed countries). Addressing the report of the parliamentary standing committee on the corrupt system of drug approval in India, the Union Minister of Health and Family Welfare, Shri Ghulam Nabi Azad has constituted a three member committee to revamp the entire drug approval procedure and examine the scientific validity for approval of new drugs without the Phase III test on the Indian population. The members of the committee are Dr VM Katoch, (Secretary and DG , ICMR), Dr. P N Tandon (President, National Brain Research Center, Department of Biotechnology, Manesar) and Dr S S Agarwal, (former Director, Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow).
Under the current system of drug approval, we, the Indians, are practically guinea pigs. Despite the parliamentary committee report and the constitution of the expert committee, the Indian market continues to be flooded with medicines without mandatory approval. I end this discussion with a small example. Nimesulide, a mid- range analgesic ideal for body aches, mild cold and feverish feelings had been banned globally in 2005 (especially for children). The side effects of this chemical include nausea, vomiting and prolonged usage causes hepatic failure. In spite of that nimesulide based medicines are extremely popular in India. NISI PLUS, NICE, SUMO are some of the over the counter available medicines containing high percentage of Nimesulide. Medicines containing this chemical are consumed by both adults and children. I admit that not all people have that kind of medical awareness but what about the quacks who still prescribe them? Because no sane doctor, worth his salt, will prescribe nimesulide!
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