One of the issues raised in the 59th Report of the Parliamentary Standing Committee on Health & Family Welfare was that of appropriate qualifications for the post of the Drug Controller General of India (DCGI), who heads the CDSCO. The main concern expressed by the committee was that unlike regulators in the US and UK both of which are usually headed by persons qualified as medical doctors, the Indian regulator was historically headed by a pharmacist. The Standing Committee describes the existing criteria as follows:

“the academic qualifications of the Licensing Authority (i.e., Drugs Controller General, India) are specified in Rule 49A and 50A of the Drugs and Cosmetic Rules. As per these Rules, the Licensing Authority (DCGI) should be (a) a graduate in pharmacy or pharmaceutical chemistry (B.Pharm) or (b) a graduate in medicine with specialization (post-graduation) in clinical pharmacology or microbiology (MD) with five years’ experience [manufacture of or testing of drugs or enforcement of the provisions of the Act]”

By necessarily requiring a candidate to have 5 years of experience in manufacturing or testing of drugs, these rules virtually disqualify all medical doctors in India because manufacturing requires engineering skills and clinical testing was largely limited to bioequivalence studies until very recently. Unfortunately, the framers of this rule never considered public health (e.g., MPH) related discipline as a requisite either. It is crucial to have medical doctors or public health professionals heading a drug regulator because the primary responsibility of the DCGI is to safeguard public health – this includes decisions related to drug approvals and clinical trials, both of which are beyond the educational qualifications for pharmacists. This is not to say pharmacists have no role – they are a key component of regulating manufacturing but this is only one component of the overall drug regulation.

The Standing Committee appears to appreciate this distinction. It comments:

“The Committee fails to understand as to how a graduate in pharmacy or pharmaceutical chemistry (B.Pharm) is being equated with a medical graduate with MD in Pharmacology or Microbiology. Apart from the obvious anomaly, with rapid progress in pharmaceutical and biopharmaceutical fields, there is urgent need to revise the qualifications and experience as minimum eligibility criteria for appointment as DCGI. The Committee is of the view that it is not very rational to give powers to a graduate in pharmacy, who does not have any clinical or research experience to decide the kinds of drugs that can be prescribed by super specialists in clinical medicine such as those holding DM and PhD qualifications and vast experience in the practice of medicine and even research.”

Furthermore, the committee also stated the following:

“On a larger plane, the Committee is disillusioned with the qualifications provided in the age old Rules for the head of a crucial authority like CDSCO. The extant Indian system is nowhere in so far as sheer competence and professional qualifications are concerned when compared with countries like USA and UK. There is, therefore, an urgent need to review the qualifications, procedure of selection and appointment, tenure, emoluments, allowances and powers, both administrative and financial of the DCGI.”

As a result of the Standing Committee’s recommendations, the Government of India constituted an Expert Committee to suggest the qualification criteria for senior level posts in the CDSCO including the DCGI. The Committee initially comprised of three persons: Mr. Satyananda Mishra, Former Secretary of the DoPT, Dr. M.K. Bhan Former Secretary Dept. of Biotechnology and Dr. Ranjit Roy Choudhury Prof. Emeritus Pharmacology. Later, the Committee co-opted two more persons, both of whom were former DCGIs: Dr. Prem Gupta and Dr. Ashwini Kumar. The decision to include the former DCGIs was a direct conflict of interest because such a review exercise requires an objective mind – former DCGIs aren’t going to admit that the existing criteria in the law under which they were appointed was flawed and that they were unfit for the job they held. It should therefore not surprise anyone that the final report of the committee hardly makes any radical recommendations. In fact, the final report is only 9 pages and is very poorly researched and reasoned. The only small mercy is that the report drafted recommendations to change the mandatory requirement of experience in testing or manufacturing of drugs and instead, allow for clinical research or other related research areas to be considered in such senior appointments. This may make it easier to appoint medical doctors to the post of DCGI. This final set of recommendations does not however delete the criteria which allows pharmacists to be appointed – it merely upgrades the criteria from a mere Bachelor’s degree to a Master’s Degree. Even these recommendations are yet to be implemented by the government.

Qualifications aside, there is very little accountablity of the DCGI toward public health. For example, in the aftermath of Ranbaxy’s prosecution in the US, the DCGI and his team undertook a tour of Brussels and St Petersburg, presumably at taxpayer expense. The pretext for this trip was to learn of international standards. It has been over two and half years since that trip, and manufacturing facilities in India continue to cited for compliance related violations by foreign regulators, while CDSCO twiddles its thumbs. One wonders what, if any, did the DCGI learn from his foreign junket?

Changing the qualification criteria for this critical public health role isn’t going to be an easy task. The rank and file of the CDSCO consists of officers who are primarily pharmacists or hold similar degrees – changing qualifications at the top is seen to impede their chances of climbing the organisational ladder. At the same time, the appointment of a person from outside the fraternity opens the door to even more accountablity which could disadvantage vested interests. A NGO by the name of Delhi Pharmaceutical Trust (DPT) has already demanded that the Ministry not change the qualification criteria. The Trust’s managing trustee told Parmabiz. “Top regulatory head positions like the DCGI involve effective implementation and overseeing drugs and pharmaceuticals import, approval of new drugs, manufacture, sale and distribution, Expert knowledge of pharmacy and pharmaceuticals along with administrative experience in these areas is vital to provide positive leadership and effective enforcement of drugs. In the current global regulatory scenario, maintenance and growth of Indian pharmaceutical sector is key to the country”. This is a myopic view of drug regulation for reasons already discussed above has a negative impact on transparency and accountability of the organization that is supposed to be the guardian of public health in the country. Even in its present form, the appointments to the post of DCGI have been fiercely litigated in the Court. This 2012 editorial in the Indian Express captures the key issues; none of which have been addressed to resolution now some four years later.