On June 6, 2016 the CDSCO published a notice announcing that it was going to revisit the Drugs & Cosmetics Act, 1940 and Rules, 1945 “to match up with the current regulatory requirements related to safety, efficacy and quality of drugs, medical devices and cosmetics”. The Ministry of Health has called for feedback from all interested stakeholders within 15 days i.e., by June 21, 2016. The comments are to be sent to the JDC (ER), HQ, CDSCO, FDA Bhawan, New Delhi at email@example.com .
The Economic Times was the first newspaper to report this on June 8, 2016 in a report available over here. Since then Money Control, India Today, Livelaw and other haves reported on the notice. Most of these newspapers reported the call for comment as late as June 13; it is not clear as to why the CDSCO is rushing the process by allowing merely two weeks for comments. Even this notice has not received wide publicity.
In any case, I was in the process of compiling a report based on all of my research over the last year. The report is available for download over here and runs into 123 pages. The report covers several of the themes already covered on this blog, along with some new issues. It covers the following topics:
Part I – The fragmented federal drug regulatory framework: This section covers the history and legality behind the creation of 36 state regulators in India;
Part II – The weak investigation & enforcement mechanism under the Drugs & Cosmetics Act, 1940: This section covers in details the various flaws with the manner in which the investigation and enforcement mechanism works on the ground. In specific, the focus is on the yawning gap between the letter of the law and its enforcement on the ground;
Part III – The absence of fundamental quality testing and recall norms: In specific, this section covers the lack of mandatory bioequivalence and stability testing norms in India;
Part IV – The 59th & 66th Report of the Parliamentary Standing Committee on Health & Family Welfare on the functioning of the CDSCO: This section covers the two famous reports of the Parliamentary Standing Committee on Health & Family Welfare which indicted the CDSCO for collusion with the pharmaceutical industry. In specific this report contains detailed follow up action for several of the issues that were first raised by the Standing Committee.
Part V – Sub-standard drugs in the public procurement system: This section covers the problem of rampant presence of sub-standard drugs in publicly funded drug systems.
I encourage everybody to download and read the report to understand the magnitude of the problem faced by the Indian drug regulatory framework. Most of the supporting documents such as the RTI replies, are available on this blogsite.