Health · Pharma & Biotech · 7 hrs ago

Wockhardt seeks 12–14 years of data protection for Indian-made drugs

Wockhardt seeks 12–14 years of data protection for Indian-made drugs

Wockhardt is urging India to protect data for locally developed drugs for 12 to 14 years.

Chairman Habil Khorakiwala said the protection should apply to products developed in India, including chemical and biological medicines.

Regulatory data protection limits how competitors can use a drug maker’s approval data when seeking approval for their own versions.

Khorakiwala said weak incentives and delays in approvals can reduce the time Indian companies have to sell new medicines and earn back research costs.

He says stronger protection could encourage drug discovery and attract investment, while helping patients gain access to newer treatments.

Wockhardt has developed antibiotic candidates for antimicrobial resistance, and its drug Zaynich received approvals from Indian and US regulators in May, according to the story.

Khorakiwala also called for closer coordination between India’s patent office and drug regulator; no government response or decision on his proposal is given.

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What people are saying

Habil KhorakiwalaWockhardt chairman
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
via Economic Times
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
via Economic Times
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
via Economic Times