CROs are upbeat as India attempts to re-structure its age-old laws and regulations that govern drugs, cosmetics, medical devices and clinical trials in an effort to weed out obsolete provisions and make them suitable for the changing times.

To this effect, the government of India has recently released a draft of the new legislation, “New Drugs, Medical Devices and Cosmetics Bill 2022,” for public review.

The new set of regulations will replace the Drugs and Cosmetics Act of 1947 which is currently in force.

The Bill proposes several reforms in clinical trials regulations. However, the tone of the new guidelines becomes more emphatic and uncompromising when it comes to ensuring the safety of the trial participants.

Experts say that through building stringent provisions for penalties including imprisonment for failure to provide compensation for injury or death resulting from clinical trials, the new laws aim to address one of the most contentious issues. Earlier, clinical trials in India drew a lot of flak as patient groups and human rights watchdogs alleged that the trial participants were nothing but “guinea pigs” in the drug testing studies carried out across India as their safety was grossly disregarded oftentimes. The judicial intervention that ensued imposed significant checks and balances on the way clinical studies were conducted in the country. As a result, patient recruitment in India became too cumbersome, and soon many players started scaling down their operations. In addition, the outcry resulting from the whole commotion received bad press on both national and international levels marring the prospects of India’s fledgling CRO industry.

It is precisely this concern for the safety of the trial participants that the new legislation attempts to address. The draft Bill states that individuals injured during clinical trials should receive medical treatment and compensation, while the legal heir of the participant should receive compensation in the event of the participant’s death. The law goes that extra mile proposing criminal penalties such as imprisonment, as punishment for those who violate the code of conduct in this aspect. It is the first time that such a measure has been considered by the government to make sure that the safety, as well as the rights of the participants, are adequately safeguarded.

Re-enforcement of the power of the licensing authority to debar the ethical committees is another significant move in the new legislation. The institutional ethics committees, which oversee the conduct of clinical trials, have also been under intense scrutiny for some time for alleged violations of the code of conduct. To make the ethical committees more accountable, the proposed rule entitles the licensing authority to debar and revoke their registration if found failing to deliver the entrusted functions.

Yet another reform that could ruffle some feathers involves the measures taken to stem the widely-alleged data dodging and other malpractices. For this purpose, the proposed law enarms drug control officials to enter into any premises related to clinical trials even without prior notice to inspect the facilities, records, data, documents, books and drugs, including investigational new drugs. Also, those who conduct a clinical trial are liable to disclose to the authorized officer all of the details of everyone involved in conducting the clinical study including that of the trial participants.

This way the new regulation is likely to arm the licensing authority with more power, enabling them to bring the errants to the book and make the studies conducted in India more transparent and the data more reliable, critics aver.

Over and above, the draft bill insists that all trials in human participants involving a new drug must be approved by the Central Licensing Authority—the apex drug regulator—signaling a clear departure from the previous law.

Notwithstanding the stringencies in certain provisions, many CROs endorse that the draft rules are forward-looking. In content and spirit, the proposed regulations appear to maintain the tenor set by the New Drugs and Clinical Trials (NDCT) rules enacted in 2019 with the aim to promote clinical research in India. NCDT guidelines made the approval and review timelines more predictable as well as attempt to bring transparency.

While the regulatory reforms paved the way to reaffirm the faith in clinical studies conducted in India, Covid-19 has brought more awareness about clinical trials across the country owing to the urgency for treatment and vaccines to deal with the pandemic.

A robust regulatory framework, say CROs, would be a great deciding factor in their journey to make India the world’s clinical trial hub, alongside their unrivaled strengths that include diversified patient reserve, skilled professionals and low-cost operations.