MC Explains | What does the Drugs, Medical Devices and Cosmetics Bill seek to achieve?

The Union government is set to replace the Drugs and Cosmetics Act, 1940, with legislation that also seeks to regulate medical devices, homeopathy and online pharmacies, apart from medicines and cosmetics. But why was there a need to replace the pre-Independence era law and what are the key provisions in the new bill? Moneycontrol explains:

What is the new Drugs, Medical Devices and Cosmetics Bill, 2022?

The new Drugs, Medical Devices and Cosmetics Bill, 2022, was drafted to keep pace with changing needs, times and technology, the government said on July 8 while putting it out in the public domain for feedback and consultation. A committee set up by the Drug Controller General of India last year to frame the new bill proposed the changes.

The bill proposes new definitions for clinical trials, over-the-counter drugs, manufacturers, medical devices, new drugs, bioavailability studies, investigational new drugs and imported spurious drugs, among others.

Importantly, it seeks to introduce regulation for online pharmacies and medical devices and penalties such as imprisonment and compensation in case of injury or death during clinical trials for drugs.

Through the bill, the Centre proposes to empower the Drugs Control Officer with prior approval of the controlling authority to enter any premises related to clinical trials to inspect the facilities, records, data, documents, books and drugs.

What are the features related to medical devices?

A Drugs Technical Advisory Board (DTAB) and a Medical Devices Technical Advisory Board (MDTAB) are planned to submit recommendations to the government from time to time on policy matters.

The draft proposes to allow the Union government to waive the requirement of conducting clinical investigations for the manufacture or import of a new medical device in public interest.

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What are the proposed provisions on online sale of drugs?

Though there is no separate chapter on e-pharmacies, the bill suggests that the Union government should formulate rules to regulate online pharmacies.

According to the bill, “no person shall himself, or by any other person on his behalf, sell or stock or exhibit or offer for sale or distribute any drug by online mode except under and in accordance with a licence or permission issued in such manner as may be prescribed.”

What do stakeholders say?

Viranchi Shah, president of the Indian Drug Manufacturer Association, said it is a positive move by the government to update an over 60-year-old law on drugs.

“We are the third-largest pharmaceutical producer in the world and if we want to reach the first or second position, it is important that the legislation governing the industry keeps pace with the changing times,” he said.

Shah said 22 committees will study the bill and send their recommendations to the government.

Rajiv Nath, forum coordinator of the Association of Indian Medical Devices Industry, expressed disappointment that the industry’s aspirations for a separate act for medical devices has not been addressed and entrepreneurs and startups, developers and engineers will still need to grapple with a complex joint law.

“Medical devices have a huge potential of investment of over Rs 50,000 crore to meet the market of over Rs 1 lakh crore and it’s time for the aspiring younger son to move on from the joint family house,” he said, referring to medical devices as the younger son and the pharma sector as parents. “The parents should realise that it doesn't mean that the son loves them less but his aspirations and practicalities need to be addressed.”

He stressed that medical devices are engineering products and not homogeneous powders, tablets or liquids that can be adulterated.

“So dubbing a rusted part of a medical device as adulterated and treating it as a criminal offence is absurdity. A law needs to be simple, reasonable and implementable and should not become a barrier to Make in India or Innovate in India initiatives,” Nath said.

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Nath, however, said the association is pleased that a separate MDTAB has been proposed.

“It’s a recommendation pending for a long time and pharmaceutical experts cannot suggest policy matters for medical devices. How can the police force decide what's good for the armed forces?” he asked.