India unveils first formal rules for drug approval panels in regulatory overhaul

The guidelines, issued by the Central Drugs Standard Control Organization (CDSCO), represent a major overhaul of India’s drug approval process and aim to make regulatory decisions faster, more predictable and transparent, according to two government officials and documents reviewed by Mint.

The guidelines standardize how Subject Expert Committees (SECs) are formed, how members are selected, and how they must evaluate applications, including the scientific benchmarks and disclosure norms they must follow. The SECs advise the Drugs Controller General of India (DCGI) on whether to clear new drugs, and their decisions have long shaped the trajectory of India’s pharmaceutical industry.

The CDSCO finalized the guidelines about two weeks ago and circulated them to SEC members for immediate implementation, the officials said.

The overhaul follows recommendations from the World Health Organization (WHO), which last year conducted a regulatory review of CDSCO and the office of the DCGI, who heads the organization. The WHO called for stronger transparency and data integrity to align India’s system with global standards.

India’s pharmaceutical industry ranks third globally by volume and 14th by value. It accounts for roughly 20% of the world’s generic drug supply and manufactures more than 60,000 products across 60 therapeutic areas. The sector also includes over-the-counter drugs, vaccines, contract manufacturing, biologics and biosimilars.

As part of its findings, the WHO urged Indian authorities to implement stronger controls to prevent, detect, and respond to substandard and falsified medical products; to launch a market surveillance program for drug quality monitoring; and to ensure that promotional and advertising claims for medicines are not misleading.

These steps are now being implemented by the DCGI and other stakeholders involved in the SEC meetings, according to the officials cited earlier.

The SECs play a central role in India’s drug approval process, advising the DCGI on whether to approve new drugs, biologics, and medical devices. Each committee includes eight experts—one pharmacologist and seven specialists from research, medical, or regulatory institutions—and requires a four-member quorum to issue recommendations.

In the absence of formal guidelines, though, these decisions were often viewed as inconsistent or opaque, delaying product approvals.

“SECs are subject expert committees involved in evaluating approvals of new drugs. Simplification and streamlining the process will help industry in getting drugs approved with predictable speed and more transparency. We appreciate the step taken by DCGI,” said Dr. Viranchi Shah, national spokesperson of the Indian Drugs Manufacturers Association (IDMA).

Emailed queries to the spokesperson for the health ministry went unanswered at the time of publishing.

Clearer mandate, tougher benchmarks

According to the guidance document, SEC members must meet strict selection criteria, including a publication record of at least 10 peer-reviewed papers and a citation ratio of 2:1. Experts are appointed for a three-year term and are expected to maintain confidentiality, impartiality, and active participation. Those who fail to attend meetings regularly may be removed.

The document specifies that SECs must offer rigorous, science-based evaluations on safety, efficacy, and risk-benefit balance. It outlines the dos and don’ts of deliberations: clinical trial waiver decisions must include clear yes/no recommendations with detailed justifications, and all discussions must remain focused on scientific and regulatory issues, excluding matters such as pricing.

“For new drug and clinical trial applications, the DCGI refers them to the SEC, an expert body that discusses proposals and offers recommendations for approval or rejection. These experts, being external to CDSCO, are not always fully aware of regulatory requirements. This often led to differing, sometimes subjective opinions, a lack of uniformity in decisions, and delays on straightforward matters. Therefore, it’s important for the committee to provide uniform decisions, maintain transparency, and offer proper reasoning for approvals and rejections,” said one of the two government officials cited earlier, who asked not to be named.

The second official added, “There were persistent discussions during SEC meetings about the absence of a guiding document to regulate or suggest proper functioning. This new guidance note outlines the ‘do’s and don’ts’ for experts. Previously, some companies had even alleged that SEC meetings were not being conducted properly.”

While officials declined to cite specific past incidents, people familiar with the matter said the lack of consistency and alignment among SEC experts, who advise on key regulatory decisions, had severely affected the functioning of the DCGI in recent years.

Industry seeks consistency

For years, pharmaceutical companies have raised concerns over the unpredictability of SEC verdicts, especially around clinical trial waivers, which are critical for expediting the launch of generics and biosimilars. The new rules aim to reduce such uncertainty by standardizing decision-making across similar products, unless clear scientific reasons justify a deviation.

The document states: “The SECs are indispensable in the CDSCO’s evaluation process due to their specialized expertise, independent perspective and commitment to quality assurance. These committees address complex scientific and regulatory challenges, fostering informed decision-making. By operating transparently and consistently across applications, SECs bolster public trust while safeguarding public health and promoting innovation in the healthcare sector.”

Public health experts have welcomed the reform.

“Any committee should operate under certain guidance, and it is always beneficial for all members of such a committee to have clarity and a common vision. It’s akin to laying down the rules of the game,” said Dr. Chandrakant Lahariya, a physician and public health expert.

He added: “The Subject Expert Committee (SEC) is an essential requirement for guiding the drug approvals and other processes in all regulatory bodies. When a new drug is needed, the SEC provides its recommendations to the apex drug regulator. CDSCO is a regulatory organization, and they need guidance from a technical expert committee to make decisions. A regulatory body needs guidance from those who deeply understand the subject.”