The government may not grant data exclusivity to pharmaceutical companies seeking to market their products in India.
Instead, it will give limited protection to them and anyone found guilty of leaking information will be prosecuted under the Official Secrets Act.
A committee constituted by the government to look into various provisions of a TRIPS compliant has, in its draft report, said the existing Drugs and Cosmetics Act did not provide any form of protection for the data submitted to the authorities for approval of drugs.
The committee has suggested changes in the Act that will allow the regulator to demand undisclosed data from pharmaceutical companies. It will also be required to protect drug data. Any leakage will have to be dealt with under the Official Secrets Act.
The companies will, however, have to specify to the regulator what information requires protection.
The committee's argument is that developed countries like the US, where strong pharmaceutical companies have advanced research and manufacturing capabilities for introducing new drugs, provide for data exclusivity only for a set period for data submitted for approval.
On the other hand, countries like India, with strong manufacturing capabilities but weak drug development facilities, prefer the trade secrets form of protection for undisclosed data submitted for approval.
Multinational companies have been demanding that data submitted to the regulator should be protected against unfair commercial use.
"The Official Secrets Act, which is generally propagated as an adequate safeguard for data protection, deals with the protection of data available with regulatory authorities and does not check reliance of such undisclosed data while granting marketing approvals to other entrants," the Organisation of Pharmaceutical Producers of India said in its representation to the committee.
It is feared that the lack of data exclusivity will affect contract research and manufacturing.
"A new drug costs Rs 500-1000 crore (Rs 5-10 billion) overseas. India could produce the same at under Rs 200 crore (Rs 2 billion), provided it can raise the level of trust among researchers," said Harinder S Sikka, senior president, corporate affairs, Nicholas Piramal India.
On the other hand, Indian pharmaceutical companies Ranbaxy, Wockhardt, Sun Pharma and Cipla are against data exclusivity on the ground that it will delay the launch of off-patent expiring drugs and result in higher prices for medicines.
"Under data exclusivity, an application to market generic version of an off-patent drug cannot be considered until after the 5/10-year period of data protection are over," said DG Shah, Indian Pharmaceutical Alliance secretary general.
With 97 per cent of the drugs going off-patent in the near future, the move can harm Indian interests.Also, as the period of protection is to be calculated from the date of marketing approval of the originator's product in India, it is very likely to go beyond the 20-year patent protection period.