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Pharma sector laments non-representation of industry in committee for framing DC&MD Act

Nandita Vijay, Bengaluru
Wednesday, September 15, 2021, 08:00 Hrs  [IST]

Pharma sector has lamented the lack of representation of industry expertise on the recently constituted committee of regulatory experts to frame, prepare and examine the present Drugs, Cosmetics & Medical Devices (DC&MD) Act. While the representatives are from the CDSCO and the state drugs control departments, there are none from industry.

According to Harish K Jain, secretary, Karnataka Drugs and Pharmaceutical Manufacturers Association and director Embiotic Labs, the present Drugs & Cosmetics Act was enacted in 1940 when India was under colonial rule and a net importer of drugs. Now, India is a leading global manufacturer and exporter of drugs, aspiring to climb up the value ladder. Against this background, an overhaul of the Act is overdue. However, we appreciate and welcome the constitution of committee to prepare the New Act.

There is need for cooperation between industry and the regulator while framing new rules or even examining the current regulations. There are many aspects of rules which the industry faces problems in adhering to. It is here, we see the need for industry’s presence on the committee to offer our constructive suggestions, he added.

The current policy of the government is to be self-sufficient in drugs end-to-end without import dependence.  To achieve this objective, the country should have end-to-end capabilities starting from basic Ingredients/KSMs up to finished dosage forms, including innovative drug delivery systems and NCEs. This requires high degree of research and global standards of manufacturing.  It is here that the presence of industry on the Committee is needed, said Jain.  

An industry observer on condition of anonymity noted that besides the absence of industry experts on the Committee, there are no state drugs control department representatives from the south, which is the hub of intellectual pharma power for research and manufacture. Since the DC&MD Act will include novel drug development, phyto pharmaceuticals, vaccines for infectious diseases, research professionals should have been included.

It is difficult for regulatory officials to think out of the box while implementing new drug regulations. This is where qualified industry personnel can guide and advise regulatory chiefs of the actual issues on the ground, the observer added.

Since India is the pharmacy of the world, our new regulations should be current, innovative, with a future perspective to think at different levels when concepts like smart factory environment are the trend. The current Covid pandemic and the pace at which reviews and approvals are happening need industry intervention to explain the development and advantages of new technology platforms utilized for research and manufacture, added the observer.

Dr BR Jagashetty, former National Advisor (Drugs Control) to MoHFW and CDSCO noted that the Committee is not complete without representation of stakeholders. Regulations are meant for the industry& trade in the interest of health of the common man.  In absence of their representation, it would be difficult for them to finalise the provisions of the Drugs & Cosmetics Act. Moreover, out of the eight members, five are from CDCSO with no representation from southern and North Eastern states. The lack of representation from pharmacy trade, e-pharmacy, pharma manufacturing, and research besides cosmetics and medical device industry is not correct.  It is not practical for the committee to seek comments from the industry for the new DC&MD Act in two months considering the inputs to be provided to frame proper provisions for the present-day pharma & medical device industry environment and patient health.


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