Wockhardt seeks 14-year data shield for India-made drugs

Mumbai: Wockhardt wants India to provide 12-14 years of regulatory data protection (RDP) for drugs that are researched and developed locally. Lack of adequate incentives and market exclusivity is holding back drug discovery and limiting patient access to newer treatments in India, said chairman Habil Khorakiwala.

Mumbai-based Wockhardt has struck success in its innovative research on a range of antibiotic drugs, bridging a global pipeline gap for difficult-to-treat infections. In May this year, the company secured approvals from Indian and US drug regulators for a breakthrough drug, Zaynich (cefepime + zidebactam), to treat complicated urinary tract infection, including acute pyelonephritis or severe kidney infections. Wockhardt has showcased six drugs to treat antimicrobial resistance (AMR).

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"My suggestion is any new product developed in any field, whether it is chemical, biological or regenerative medicine, if that product comes out of India, it should get 12-14 years of data protection," Khorakiwala told ET in an interview. Several innovative medicines marketed globally are not launched in India, he said, depriving patients of latest lifesaving treatments.

According to a recent study by consulting firm IQVIA, innovative drugs are launched in India with a delay of at least 3.95 years compared with their global debuts.

This is the first time that a major Indian drug maker has spoken in favour of regulatory data protection, with a caveat that such provision should apply for Indian innovations.

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"What we are losing out with this patent law (in India with no data exclusivity provisions) is also the availability of new life-saving drugs," Khorakiwala said. The debate, he added, "Should not be seen in a very narrow perspective of only price, but in an overall healthcare perspective." It should also weigh patient access, domestic research capabilities and India's ability to attract global pharmaceutical investment.

Delays in regulatory approval system leave domestic innovators with three to four years less effective patent life than in the US and Europe, he said. Time lost at different stages of the process can substantially shrink the commercial (sales) window, he said.

The disadvantage is greater for companies new to drug discovery, which may take longer than multinationals with decades of experience. "If Indian companies have to innovate, they are on a learning curve. They may take a little longer, even though they have filed the patent, to get the product to the market," he said.

Wockhardt itself lost several years of commercial opportunity to such delays, he said.

Data protection would offer a cushion. "Even if I am late on a patent because I was delayed, I should get at least 10 years of data protection. That incentive is very important," he said.

Khorakiwala called for closer coordination between India's patent office and the approval process of the drug regulatory agency. The Central Drugs Standard Control Organisation (CDSCO) should have access to relevant patent information and take cognisance of patents granted in India when approving competing products, he said.

"In India, the Drug Controller General of India has no connectivity with the patent system when it grants approval," he said, adding that, in his view, government bodies should take cognisance of patent matters. "When the issue comes up, regulators point to the absence of a corresponding provision in drug rules," he said.

"There has to be this kind of government connectivity with the health ministry to consider patents and declare what patents are given in India. We are not talking of patents given outside India, but those granted in India," he said.

The regulatory system needs upgrading to US and European standards, he said.