In my past blogs, I have documented how the CDSCO and the Drugs Consultative Committee (DCC) have taken decisions that adversely affect public health and give the industry a free pass even in cases where there is clear evidence of the industry breaking the law. Leadership and integrity of the national health regulator is an important factor in how it responds to advancing science. When members of the industry intentionally produce and sell substandard drugs in the country, it is the responsibility of the national health regulator to prosecute them to the fullest extent of the law.
A recent example of the difference in approach between the national regulators of India and US was how the US FDA responded to the complexity of drug formulations and the rules governing bioequivalence. A few weeks ago, the US regulator released 38 new and revised guidance documents that address the challenges of how to assess therapeutic equivalency of generic drugs. Each document also contains information on what analytes should be measured, what dissolution test methods should be used and sampling times.
Issues with existing guidelines for conducting bioequivalence studies was first pointed out to the FDA by People’s pharmacy. They provided conclusive patient outcome data to the regulator about generic Wellbutrin which made the US FDA reconsider its guidelines for establishing therapeutic equivalence of generic drugs. The arguments supporting revision of existing guidelines were explained in this peer-reviewed paper. With mounting evidence, the US regulator initiated a process of reevaluating its approach to therapeutic equivalency of generic drugs and the result is a completely new approach. Earlier this year, the US FDA provided product-specific recommendations for 31 different active pharmaceutical ingredients (APIs) linked to new generic drugs and revised recommendations for 11 APIs. Included in the latest release are guidelines for Everolimus (Novartis’ blockbuster cancer and transplant treatment) and Viekria Pak (Abbvie’s Hepatitis C blockbuster). These drugs were approved in 2009 and 2014 respectively and have no generic equivalents in the market today. This shows that the agency is thinking ahead in providing guidance to the industry which may be working on development generic therapeutic equivalents for these drugs after they go off patent.
Compare this action to how the DCC issued guidelines to undermine therapeutic efficacy of generic drugs sold in India by giving the pharmaceutical industry a free pass when it comes to prosecuting manufacturers of substandard drugs. While the CDSCO guidelines for establishing bioequivalence mirror those that were followed by the US FDA until very recently, the DCC in its 47th meeting held in July 2014 proposed that bioequivalence studies for generic drugs be deemed optional for products sold in India under the guise that infrastructure to conduct those studies doesn’t exist in the country. We all know how many CROs exist in the country, so this argument is blatantly false. What is more ridiculous is that in the same breath, the DCC recommended that bioequivalence studies be conducted for the product made for export. This action clearly undermines the law of the land, the Drugs & Cosmetics Act. Actions such as these go the root cause of the dysfunction within the CDSCO and its function; this is a direct influence of the industry lobby exercising its influence over policy making at the expense of national health.
This is the reason why, in addition to a new set of laws governing manufacture and distribution of drugs, India needs a fundamental change in leadership of the national regulator. As the Parliament Standing Committee said, leadership at the CDSCO is beholden more to the industry’s agenda and interests than the public health of the citizens of India. Unless we bring people with unimpeachable integrity to lead this organization, new laws and regulations will have limited effect on its function.