A committee of secretaries has proposed that in the interest of better and more effective regulation, the period for which a new drug is considered “new” should be extended to 10 years instead of the current four. As per Rule l22E of the Drugs and Cosmetics Rules, 1945, “a new drug shall continue to be considered a new drug for a period of four years from the date of its first approval”
Regulatory requirements are different and more stringent for new drugs and data on post marketing surveillance has to be periodically submitted. The move has raised the hackles of the Indian pharma industry which fears that 10 years would eventually be used as a precedent for data exclusivity too and thus stagger the entry of generics, benefitting MNC pharmas that hold most product patents. The committee comprising the secretaries of DIPP, health, pharmaceuticals, the CEO of Niti Aayog and a joint secretary in the PMO was formed at the behest of the PMO to look into ways to promote the Indian pharmaceutical industry, to ensure ease of doing business while maintaining quality.
The committee has, according to sources, mooted the idea of changing Rule 122E to say 10 years instead of four for a new drug as it was felt that the Drug Controller General of India (DCGI) is better equipped to do data monitoring. After the period specified in Rule 122E is over, state governments give product licences and regulation too is their domain which is where quality control often slackens, the committee felt. “It was felt that monitoring the data for ten years gives better opportunity to look out for adverse drug reactions and the matter remains in the domain of the DCGI. It is not final yet and a technical group in the office of the DCGI is working out the final details. We will take all stakeholders into confidence but we need to understand that quality is paramount when it comes to drugs. Once licensing moves to states, things change,”explained a source.
Indian pharmaceutical companies are not happy with the proposal. “We are concerned that this (extension of new drug validity period from four years to ten years) should not become a precedent for l0-year data exclusivity, if and when the government succumbs to the US pressure and concedes data exclusivity. The data exclusivity is a TRIPs plus measure. Several eminent scholars, researchers and institutions have advised nations against providing data exclusivity as it would compromise access and affordability. The Parliamentary Standing Committee on commerce had also outright rejected the data exclusivity,” wrote DG Shah, secretary general of the Indian Pharmaceutical Alliance in a letter to the secretary DIPP.
In most countries around the world — India is not one of them but is under intense pressure from western countries especially the US to join the club — a period of data exclusivity is usually granted to the patent holder company. The company that first brings a drug into the market is bound by regulatory norms to submit data on the safety and efficacy of that medicine. This data is obtained from animal testing and human trials and is very investment intensive. Subsequent applicants for the same drug only have to show equivalence so that they start with a financial advantage and can hence market the same medicine at a less price — what is known as a generic drug.
Speaking to The Indian Express, Shah said: “India currently does not give data exclusivity but there is pressure from the US. We are concerned that this 10 years will be used as a precedent for data exclusivity — in the name of ease of doing business the government is moving towards ease of gathering commercial intelligence. The logic of better regulation does not wash. What will change in ten years? Why not instead talk to the regulators in the five states that account for 85-90 per cent of India’s drug production — Gujarat, Maharashtra, Tamil Nadu, Andhra Pradesh and Karnataka and make it mandatory for all companies to do bioavailability and bio equivalence studies for their products.”