The government’s think tank, Niti Aayog, has proposed setting up a clone of the US FDA in India to be the umbrella body of all the other regulators in India, such as the Central Drugs Standard Control Organization (CDSCO), the Food Safety and Standards Authority of India (FSSAI) and the proposed Medical Device Authority (MDA). So why does India need a super regulator?
- Common objective: Currently, each of the regulators concerned with products certified for human consumption — medicines, cosmetics, food and medical devices — operate independently even though the heads of the CDSCO and the FSSAI report to a Joint Secretary in the Ministry of Health. In the US FDA model, there are eight sub-divisions to tackle regulatory issues in their respective sectors — food, drugs. cosmetics, medical devices, radiation emitting products, biologics (which includes vaccines and blood), veterinary products and tobacco products. In the Niti Aayog proposal, the Indian FDA will be headed by an IAS level officer of the rank of additional secretary in the health ministry.
- Reducing workload? India as yet does not have a separate regulator for medical devices— 22 of which are categorised as drugs and have DCGI oversight while the rest are sold without any standards governing them. In fact, for imported devices, the CDSCO relies on US FDA certification or an EU certification to allow their use in India. Similarly, for veterinary products, the CDSCO only last year approved the setting up of a separate cell within the organisation to monitor the “marketing authorisation, import, registration, licensing and field trials of veterinary vaccines and drugs.” In this case, it isn’t just the impact of the medicines and drugs on the animals that needs to be reviewed — with many of them being used to produce food for human consumption, such as poultry and meat products, their impact on humans also needs to be known.
- Global respect: India’s drug manufacturing companies have earned for themselves a notorious reputation for cutting corners in their manufacturing practices — with the likes of the now-defunct Ranbaxy, Wockhardt and Dr Reddy’s Laboratories coming in the US FDA’s crosshairs. In 2018, US FDA inspections of Indian drug manufacturing facilities went up 18% to an all time high — with more than 200 drug quality checks. One of the reasons India is under the US FDA lens is that it’s the world’s largest exporter of generic drugs, making 40% of all new generic drugs that received the FDA’s approval last year. Quality issues about Indian made generic drugs became so frequent that the US FDA opened two offices in India, in Delhi and Mumbai, in 2009. With the USFDA’s norms being among the most stringent, India will be hoping its own FDA-lookalike will earn the same respect.