Protecting drug data $100 bn business

The pharmaceutical industry is eagerly awaiting the inter-ministerial committee report on data protection as it may open new vistas for it.

"If data protection is allowed, potential worth $100 billion is there in contract manufacturing and research in India in the next decade," says Harinder S Sikka, senior president, corporate affairs, at Nicholas Piramal, referring to the untapped outsourcing opportunities.

The committee has experts and representatives from the department of industrial policy and promotion (DIPP), ministry of commerce, and ministry of health. It is dealing with an issue over which opinions are sharply divided in the pharmaceutical industry.

To begin with, the Drugs Controller-General of India, under Schedule Y of Drugs and Cosmetics Act, 1940, demands exhaustive and confidential information from the first applicant of a new chemical entity (NCE).

Though there is an Official Secrets Act, there is nothing confidential about the information furnished. It is the protection of and access to such data that the contentious issue pertains to.

The question of data protection is intrinsically linked with the commercial cost and benefit such data entail. Estimates range from $50-100 million for an NCE, according to a source in the ministry of chemicals and petro-chemicals.

But, it is $800 million, as per ZH Charna, director, Organisation of Pharmaceutical Producers of India. And there are still others, like Gajanan Wakankar, executive director, Indian Drug Manufacturers' Association, who says that for drugs that have already been introduced elsewhere in the world, the costs for their introduction in India are bare minimum.

Charna feels data protection needs to be implemented as "a matter of principle". Quiz him on the prospects of high-end manufacturing, clinical outsourcing and whether the prospects will receive a boost under a regime of data protection, and his answer is strongly in the affirmative.

An official says international perceptions will be favourable with a clause that ensures data to be protected. Wakankar, however, says even if this were to be provided, India will get only low-end R&D and outsourcing work, as MNCs are notorious for not transferring technology.

"Even countries which have such provisions have not seen any real technology transfer", he adds.

Sikka says the West will never research the drugs for ailments specific to the Indian sub-continent . If Indian companies, too, have no incentive to research for fear of plagiarism, there shall be none to develop drugs for these diseases.

He laments that Nicholas Piramal had to take its anti-cancer and anti-AIDS drug trials to Canada because of data protection, or the lack of it.

Data protection is a euphemism for data exclusivity. Data that are protected for a fixed period will require the submission of the entire data by subsequent applicants.