D&C Act 1940 should be reframed: Pharma stakeholders

Pharma industry stakeholders feel that the Drugs and Cosmetics Act needs to be reframed to streamline drug regulatory affairs in India.

Dr Rajesh Gupta, All India Head, Laghu Udyog Bharati Pharma Wing and President of Himachal Drug Manufacturers Association, said, “The Indian pharma industry is still following the Drugs and Cosmetics Act of 1940, which was formed way back in British era to promote a ruling attitude rather than facilitation. It focussed more on criminal procedures and is not meant for a democratic set-up. We are entering the 75th year of independence but the Drug and Cosmetic Act, 1940 provisions bind Indian regulators to treat everything from a criminal perspective. We feel that the entire Drugs and Cosmetics Act should be reframed and it needs to be drafted after assessing the industry’s present scenario and growth prospects.”

He elaborated, “Under the present Drugs and Cosmetics Act 1940, any kind of negligence is treated as a criminal offence i.e. a silly labelling mistake shall invite criminal proceedings and the company has to pay hefty amounts for undefined periods to obtain a legal remedy, as the case continues in the court for years. This damages the company’s position in the market and affects other activities as well. A democratic thought process will help define genuine manufacturers to protect and promote, while the spurious ones will be punished.”

“Therefore, we are planning to make a joint industry representation to the Department of Pharmaceutical (DoP) requesting the authorities/policymakers to consider reframing the present Drugs and Cosmetics Act. We anticipate that if the government considers our request then it will be a crucial step towards protecting genuine manufacturers and encouraging the industry to become Aatma Nirbhar.

Harish Jain, Secretary, Karnataka Drugs and Pharmaceutical Manufacturers Association highlighted, “Drugs and Cosmetics Act 1940, enacted during British Rule is due for review and a complete overhaul in view of the fact that India is now a net exporter of drugs, and recognised as the third-largest in the world in terms of volume. Nearly hundreds of countries are dependent on India for the supply of essential medicines and more importantly, the federal nature of the country wherein, we have both State and Central authorities. The act should now reflect the stringent regulatory nature of our drug regulatory system. At the same time, it should be sensitive to the affordability of the medicines for the masses. The time has come to include good distribution practices, including supply chain logistics.”

Giving insights about initiatives to reframe the D&C Act 1940, Dr B R Jagashetty, Legal Consultant and Arbitrator appointed by Karnataka High Court, Former National Adviser (Drugs Control) to MoH&FW and CDSCO and former Drugs Controller Karnataka, informed that during 2014 – 15, he was appointed as a National Advisor (Drug Control) to the ministry of Health and Family Welfare (MoHFW) and CDSCO at Government of India, after retiring as the Drugs Controller for the State of Karnataka. At that time, he had suggested to the then, joint secretary of MoH&FW that instead of making various and numerous amendments in the existing Drugs and Cosmetics Act, 1940 it is high time that steps were initiated to reframe the entire Drugs and Cosmetics Act afresh. It should incorporate suitable amendments based on present and future circumstances. It must be called Drugs, Cosmetics and Medical Devices Act, 2014 or so. He informs, “Although we received a good reaction that time when the Draft Drugs & Cosmetics (Amendment) Bill, 2014 comprising various amendments were submitted, further developments are not known, nothing has been done so far. However, the new and final Drugs and Cosmetics Act should be framed and released with long term strategies for a minimum of 25 -30 years, after repealing the existing one by the concerned authorities in government and making an assessment of present and future circumstances.”

He stated that, as per the present Drugs and Cosmetics Act, 1940, if the pharma manufacturer/trader is found guilty of even a minuscule offence, then as defined in the said Act it is reported as a criminal offence. However, it is suggested that instead of addressing all offences as criminal, it should be made viable for both, the government as well as the industry by incorporating certain offences such as compounding offence or economic offence so that culprits are punished immediately. This will reduce the number of online cases in the courts, while both the Centre and state governments will get revenue too.”

Another suggestion he made was about bringing uniformity in the name, functionality mechanism and recruitment procedures of all seven government drug testing laboratories. Shetty informed that he had submitted a report to the respective authorities of MoHFW suggesting that at least four laboratories should be appellant drugs testing laboratories instead of having just one appellant drugs testing laboratory called the Central Drugs Testing Laboratory (CDL) at Kolkata. He feels that this will increase efficiency and decrease the workload in addition to bringing uniformity in functioning.