India launches formal rules to fix, streamline drug and device clearances

India has released its first official set of guidelines on how expert panels should review and approve new drugs, medical devices, and biologics, Mint reported. This move is aimed at fixing problems of unclear and inconsistent approvals that have previously slowed down drug launches and weakened the pharmaceutical industry's trust in the system.

These new rules, issued by the Central Drugs Standard Control Organisation (CDSCO), are designed to improve how India regulates new medical products. The goal is to make the approval process quicker, more transparent, and predictable, the news report said.

The guidelines define how Subject Expert Committees (SECs) should be formed, how experts are chosen, and how they must review applications. These SECs play a key role in advising the Drugs Controller General of India (DCGI) on whether a product should be approved.

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

Why this is important for India’s pharma sector?

India’s pharmaceutical industry is the world’s third-largest by volume and 14th by value. It supplies around 20 per cent of the global generic drug demand and manufactures over 60,000 products across 60 therapy areas. The sector includes generic medicines, vaccines, biologics, over-the-counter drugs, and more.

In its review, the WHO had asked Indian authorities to better track low-quality or fake medical products, start a market monitoring programme, and ensure drug advertisements are not misleading. Many of these suggestions are now being followed by the DCGI and those involved in SEC meetings, the news report said.

Stricter criteria and structured evaluations

Each SEC has eight members — one pharmacologist and seven other experts from research or medical fields. At least four members must be present to make a decision. Earlier, the lack of formal rules often led to delays and confusion in the approval process.

Now, SEC members must meet strict criteria, such as having at least 10 published research papers and a 2:1 citation ratio. They are appointed for three years and must follow rules on confidentiality, impartiality, and attendance. Those who miss meetings without good reason can be removed. The new document also says SECs must evaluate drug safety, effectiveness, and risks using strong scientific standards. Decisions like clinical trial waivers must be clearly justified, and discussions must only focus on scientific and regulatory issues — not pricing or business concerns, Mint reported.

US hits Indian exports with blanket 25% tariffs

The US government has decided to impose a 25 per cent tariff on all Indian exports starting August 7 — without any exemptions.

This new order removes earlier tariff breaks given to products like pharmaceuticals, electronics, and energy goods. GTRI founder Ajay Srivastava said this is one of the toughest trade measures by the US against India, news agency PTI reported.

India’s top export items to the US — like smartphones ($10.9 billion), petroleum products ($4.1 billion), and pharmaceuticals ($9.8 billion) — will be hit hardest. Srivastava said these sectors have high import content and low local value addition, making them vulnerable to the tariff hike.

USFDA actions slow down Indian drug approvals

Meanwhile, Indian drugmakers are also facing regulatory challenges abroad. In the first quarter of FY25, the US Food and Drug Administration (USFDA) sharply reduced the number of abbreviated new drug application (ANDA) approvals for Indian firms, according to a report by The Times of India.

Companies like Cipla, Sun Pharma, Dr Reddy’s, Lupin, and Aurobindo Pharma are under increased inspection. Aurobindo’s approvals dropped due to issues at its Unit III plant. In May, the company got seven observations from the USFDA at its Bhiwadi facility and earlier three more for its Andhra Pradesh site.

Cipla also got six observations for its Goa plant in June. In a filing, the company said it was committed to addressing the concerns in time.

A Business Standard report said that the USFDA's Centre for Drug Evaluation and Research recently found that 11 per cent of Indian drug manufacturing facilities had violations, including data integrity issues.