Streamlining Drug Regulatory Affairs in India

Central Drug Standard Control Organization (CDSCO) is revisiting the existing Drugs and Cosmetics Act, 1940 and Rules 1945 and has issued a notice seeking feedback on the existing Drugs and Cosmetics Act and Rules. This is a great opportunity for the drug industry to convey their concerns and challenges to CDSCO.

The Act is primarily meant for regulating the import, manufacture, distribution and sale of drugs and cosmetics, to ensure their safety, efficacy, quality and conduct of clinical trials. With time, we have seen several amendments to the Drugs and Cosmetics Act, 1940 (Act) but still it is lagging behind when it comes to regulation of today’s advanced market.

With the development in technology, and the requirement of regulating additional aspects, like medical devices and biosimilars (similar biologics), there has been requirement to relook at the existing Act. In today’s cyber world, the onset and advancement of online activities like online purchase and sale of drugs and cosmetics need the existing Act to be reframed and to have proper guidelines to ensure safety and efficacy of the drugs and cosmetics.

The pharmaceutical industry is growing with tremendous speed. From last few decades, we have seen a gigantic advancement in the technology especially in the field of biotechnology, biologics, different dosage and dosage forms, fixed dose combinations etc. of drugs. Introduction of nanotechnology in the field of small complex molecules and biosimilars in the field of large complex molecules has given the pharma industry a new face altogether. Hence, there is a need to revisit the existing Act to make it consistent with the advancement of the industry and technology.

Some of the issues faced by the industry are delay and inconsistency in the implementation of the Act, especially by the different State Regulatory Authorities. Lack of clarity of procedure has also been a challenge, from both the regulator, as well as the user side.

In recent past, the Indian pharmaceutical industry has also been in news by receiving several warning letters and red signals from United States Food and Drug Administration (US-FDA) for poor quality and documentation.

The revisited Act is expected to capture the quality issues to further strengthen the Indian Pharma Industry. We may also see inclusion of appropriate provisions in terms of regulation of investigational new drugs, biologics, biosimilars, medical devices, thereby bringing more clarity to the users of this system.

With the government seeking feedback to revisit the existing Drugs and Cosmetics Act, 1940 and Rules 1945, we can expect some substantial overhauling in the existing Act to match up with the current regulatory requirements related to Safety, Efficacy and Quality of Drugs, Medical Devices & Cosmetics.

The interested parties can submit their feedback, based on their experience, by June 21, 2016 to