A new drug is considered ‘new’ for 10 years instead of the current four and it will be followed from the date of its first approval. A committee of secretaries has proposed that period in the interest of better and more effective regulation. The committee comprising the secretaries of DIPP, health, pharmaceuticals, the CEO of Niti Aayog and a joint secretary in the Prime Minister’s Office (PMO) was formed at the behest of the PMO to look into ways to promote the Indian pharmaceutical industry, to ensure effortlessness quality maintenance.

Regulatory requirements are different and more powerful for new drugs and data on post marketing surveillance (PMS) has to be periodically submitted.

Changing Rule 122E to say ten years instead of four for a new drug gives better opportunity to look out for adverse drug reactions and the matter remains in the domain of the DCGI. After the period specified in Rule 122E is over the state governments give product licences and regulation. It is not final yet and a technical group in the office of the DCGI is working out the final details. Additional information on India’s current process for registering medical devices, cosmetics, IVD’s are available in our blog section.