Thursday, April 24, 2014

A damning indictment of drug regulation in India - How the CDSCO works

A comment on a previous post asking about quality control of drug manufacturing in India led me on a search to try and understand how the process works in this country. The major regulatory body in India is the Central Drugs Standard Control Organization (CDSCO), headed by the Drug Controller General of India (DGCI) and under the Ministry of Health and Family Welfare. There are also state-level regulatory authorities. As per the CDSCO's website, "Under the Drug and Cosmetics Act, the regulation of manufacture, sale and distribution of Drugs is primarily the concern of the State authorities while the Central Authorities are responsible for approval of New Drugs, Clinical Trials in the country, laying down the standards for Drugs, control over the quality of imported Drugs, coordination of the activities of State Drug Control Organisations and providing expert advice.."


Given that the CDSCO's mandate places it on par with the FDA(USA), the EMA(European Union) and other such regulatory bodies, I was interested in learning more about the organization. That is what led me to this report, presented to the government in 2012. Although two years old, the findings detailed in this report are so alarming that I thought it well worth my while to devote a few posts to them. I'll be running these as a short series, and today's post is an overview of the report and some general findings regarding the setup and functioning of the CDSCO. Later posts will have more details of the specific findings discussed.

The report in question is the 59th report of the Department-related Parliamentary Standing Committee on Health and Family Welfare, examining the functioning of the CDSCO. The Committee was made up of members of the Rajya Sabha and the Lok Sabha as well as administrative officials, who solicited views and information from the Secretary, Department of Health and Family Welfare, as well as CDSCO officials. Committee members also visited state drug testing facilities in Chennai, as well as the private testing laboratories of Bangalore-based Biocon Pvt. Ltd.

I've read a few government reports in my time and they generally tend to be dry as dust. Not this one, which is both blunt and scathing in its documentation of the many, many problems besetting the CDSCO. Here's a list:




  • The mission statement of the CDSCO is to "meet the aspirations...demands and requirements of the pharmaceutical industry." There is no mention of safeguarding public health, which is probably the most important function of such an organization, and indeed finds mention in the mandate of drug regulatory authorities in several other countries. From the report, "The Committee is of the firm opinion that most of the ills besetting the system of drugs regulation in India are mainly due to the skewed priorities and perceptions of CDSCO. For decades together it has been according primacy to the propagation and facilitation of the drugs industry, due to which, unfortunately, the interest of the biggest stakeholder i.e. the consumer has never been ensured." Which is basically to say that the CDSCO is far too cozy with drug manufacturers to treat consumers fairly, and ensure that their rights are duly safeguarded.

  • Drug regulatory functions in India are distributed between the CDSCO and state-level drug authorities. Technically speaking, quality control monitoring is a state-level subject. So while the CDSCO can recommend that certain manufacturing plants be penalized for failure to meet quality standards, it can't actually force the state to take any action against errant manufactures. This, in spite of there being legislature (Section 33P of the Drugs and Cosmetics Act) which permits the Central government to issue directives to the state government to ensure that the laws relating to drug manufacture are being uniformly and correctly implemented.

  • Regulatory authorities across states are poorly co-ordinated. The report mentions that it would have been very easy to set up a state-level database which would allow drug regulatory information to be easily shared across states and even at the central level. However, "no serious efforts seem to have been made in this regard", observed the Committee, and recommended that "at least now" the Ministry of Health and Family Welfare would spearhead the development of such state and central-level databases.

  • The CDSCO is woefully understaffed. At the time of the report, there were nine officers who were expected to annually review approximately 20,000 applications, attend over 200 meetings, attend to 11,000 public/industry representatives, respond to 700 parliament questions and participate in 150 court cases. In addition, they had to attend advisory committee meetings, prepare guidance documents, provide input for the amendment of government acts as needed, develop a pharmacovigilance programme,  train newly recruited staff and complete any other tasks as assigned by the ministry. Less than 40% of all permanent staff positions had been filled as of October 2011, and on average the recruitment process took between 12 to 15 months. The creation of an additional 1045 posts was proposed as being necessary to handle the workload, and a massive increase in infrastructure and organizational capacity would be required as well.

  • The Committee was highly critical of the prescribed academic qualifications for the post of the DGCI; a bachelor's degree in pharmacy is sufficient. In contrast, a medical degree is required for some of the lower posts. As per the report,"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...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...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." The DGCI is also required to have experience in the "manufacture or testing of drugs or enforcement of the provisions of the Drugs and Cosmetic Act for a minimum period of five years". A requirement like this effectively bars otherwise well-qualified medical professionals from the position of DGCI.

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