India Pharma Outlook Team | Wednesday, 04 November 2026
Drug research is becoming an important frontier for India's pharmaceutical industry, which has built its global strength on affordable generics supplied to millions of patients worldwide.
The next challenge lies in discovering and developing original treatments that can strengthen India's innovation capabilities.
Wockhardt offers a compelling example through Zaynich, its breakthrough antibiotic targeting difficult-to-treat infections. Now, Chairman Habil Khorakiwala wants India to introduce 12–14 years of regulatory data protection for medicines developed domestically.
His proposal raises a critical question: Can India keep inventing new medicines if innovators lose years of commercial opportunity to regulatory delays?
Regulatory data protection (RDP) prevents competitors from using an originator's clinical trial data to secure approvals for competing medicines during a defined period. Khorakiwala wants India to extend this protection to products researched and developed within the country. This marks the first public push for regulatory data protection from a major Indian drugmaker, with a specific focus on domestic innovation.
The proposed 12–14-year protection period addresses a significant disadvantage for Indian innovators. According to Khorakiwala, regulatory delays leave domestic companies with three to four years less effective patent life than their counterparts in the US and Europe.
An IQVIA study reinforces this concern. Innovative medicines reach India at least 3.95 years after their global debut, creating another gap between discovery and patient access.
Also Read: India's Life Sciences Shift: Commercialising Research & Localising Critical Manufacturing
Drug discovery requires years of scientific investment, clinical testing and regulatory preparation. Every additional delay reduces the time companies have to recover these costs and generate returns from successful medicines.
Wockhardt has experienced this challenge firsthand. Khorakiwala said the company lost several years of commercial opportunity because of regulatory delays. The disadvantage becomes particularly severe for Indian companies still developing their drug discovery capabilities.
The consequences extend beyond business performance. Khorakiwala pointed out that several innovative medicines available globally never reach Indian patients. Others arrive years after their international launch, restricting access to newer lifesaving treatments.
A stronger incentive framework could help address these gaps by:
India's generics leadership remains important, but innovation increasingly requires a complementary policy approach.
Khorakiwala also wants better coordination between the Indian patent office and the Central Drugs Standard Control Organisation (CDSCO). He argued that CDSCO should access relevant patent information and consider patents granted in India while approving competing products. Currently, the drug approval system lacks direct connectivity with the patent system, creating regulatory gaps for domestic innovators.
He also urged India to upgrade its regulatory framework towards US and European standards. Importantly, Khorakiwala wants policymakers to assess the proposal beyond medicine prices. Healthcare outcomes, domestic research capabilities and long-term patient access deserve equal consideration.
India has mastered the challenge of making medicines affordable. Its next pharmaceutical ambition involves creating stronger conditions for medicines to originate within the country.
Wockhardt's proposal places drug research incentives at the center of this transition. Whether India adopts regulatory data protection will shape an important debate about how the country supports domestic innovators while protecting patient access and affordability.
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