In opposition from within the government to a proposal that the period for which surveillance data needs to be submitted to the Indian drug controller for a new drug be increased from four years to ten, commerce secretary Rita Teotia has written to the health ministry saying that the move will delay the entry of generic drugs in the Indian market.
A team at the office of the Drug Controller General of India is currently working on a proposal mooted by a committee of secretaries to change 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”. While industry has been up in arms against the move following apprehensions that this may be used as a precedent to grant data exclusivity to patent holder companies, Teotia in her letter has echoed those concerns.
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“Data Exclusivity is a TRIPs plus provision and gives undue benefit beyond the period of ‘patent’. As per the current regime a new drug enjoys this status for 4 years from the date of its first approval in India. Once the patent period is over, generic companies are free to launch their products which generates local competition leading to greater access and affordability of medicines in the market. Therefore any decision to increase Data Exclusivity period for new drug from 4 years to 10 years would virtually amount to extending monopoly beyond the period of patent and therefore it would be highly detrimental to exports as well as to availability of generic drugs in the domestic market,” Teotia wrote in her letter. The generic exports of Indian pharmaceutical companies is estimated to be in the range of $25 billion – in fact India is the largest supplier of cost effective generics to the developed world and also to the developing nations.
During the four year period during which a new drug is so considered, all applicants seeking to market it are required to conduct bioequivalence study. For manufacture of drugs which are no more new i.e. after completion of four years from the date of approval, licences to manufacture such drugs are issued by the concerned State Licensing Authorities. However, Drugs and Cosmetic Act and Rules do not require an applicant to submit bioequivalence study data for drug formulations which are no longer considered as “new drug. The committee that made the recommendation to extend the new drug period comprises of the secretaries of DIPP, health, pharmaceuticals, the CEO of Niti Aayog and a joint secretary in the PMO. It was formed at the behest of the PMO to look into ways to promote the Indian pharmaceutical industry. The rationale behind the proposal sources maintain, is merely to tighten drug regulation and not throttle the generics market but Teotia has in her letter once again raised the Data Exclusivity bogey that has been haunting the industry.
Interestingly a meeting of the Drug Technical Advisory Board (DTAB) in June this year had decided in favour of making bioequivalence study mandatory for all drugs, effectively making the new drug categorisation redundant. “The DTAB, after deliberations, recommended that submission of bioequivalence data should be made mandatory prior to grant of licence for manufacturing drugs in the country…For the drugs already marketed in the country, three years time may be given of submission of BE study data. The Board has further recommended that a Group should be constituted to lay down the modalities for identification of the reference drug for the conduct of BE studies,” reads the minutes of the meeting held on June 27.