India aspires to move from being only a large manufacturer of medicines to becoming a global leader in pharmaceutical innovation.

When a company develops a truly new medicine, it must invest significant time and money in research and clinical trials to prove that the treatment is safe and effective. However, under the current regulatory framework (NDCT Rules 2019), there is no guaranteed time-bound protection for the clinical data generated by the first company that undertakes these trials.

This means that other companies may be able to seek approval for similar products without making the same level of clinical investment.

Many believe this creates an imbalance that may discourage Indian companies, especially MSMEs, from taking bold scientific risks and investing in breakthrough treatments. In therapeutic areas where India faces rising disease burdens, including eye diseases, diabetes, cancer, and other chronic conditions, we need more research-driven innovation, not less.

India cannot become an innovation-led, value-based pharmaceutical powerhouse unless we create a policy environment that rewards scientific effort and responsible risk-taking.

We are not asking for monopoly pricing or reduced access to medicines. We are asking for a fair and balanced system that:

• Encourages companies to invest in clinical research

• Supports domestic innovation and MSMEs

• Promotes ethical and fair competition

• Ensures India remains globally competitive

• Protects patient access and affordability

We respectfully urge policymakers to evaluate appropriate reforms within the current regulatory framework to support genuine innovation while safeguarding public interest.

India has the scientific talent. Now we need the right policy support to unlock it.