India Drug Regulations Update

With over 1.4 billion people, India is currently the 3^rd largest market in Asia after China and Japan. With geo-political tensions mounting between the US and China, more Western drug companies are thinking about manufacturing and sourcing drugs and drug components from India. Accordingly, India is implementing some new drug regulations to upgrade its drug quality.

In early 2024, the Indian government promulgated a notification saying that large Indian drug companies had 6 months to improve their quality and 12 months for smaller drug companies. For example, more serious testing needs to be done before Indian drug companies can sell their products. Also, even after sales, drug makers need to keep more products and substances internally to do follow-up testing as needed. Indian raw material and packaging suppliers must now be audited by their Indian finished drug manufacturers. Furthermore, India’s state drug authorities were granted more authority to oversee local drug production. Finally, the US FDA will increase the number of inspectors in India too.

Also in early 2024, India’s CDSCO established a new program called the National Single Window System (NSWS) program and portal to carefully watch healthcare products it has already regulated. This portal will also allow government entities, import-export departments and others to easily see information on approved drugs, devices, and related healthcare products. All applications, approvals, and other regulatory records will soon be accessible on the NSWS portal too. This will improve access to healthcare issues that have not previously been connected to the internet.

India has also started a pilot program for drug procurement in the cancer area. The pilot program has been able to reduce the prices of about 40 cancer drugs, leading to lower prices and substantial savings. This program has been developed by India’s National Cancer Grid (NCG). This pilot program may lead to a new direction for future Indian procurement practices.

In addition, India has promulgated a new ethical program for drug marketing. This new regulation is called the Uniform Code for Pharmaceutical Marketing Practices (UCPMP). Thus, all pharmaceutical associations now will need to set up “ethics committees” to monitor drug companies and their marketing practices including what sales reps can and cannot do, what promotion is valid, etc. There will now be more oversight at medical conferences, illegal bribes, the distribution of free samples, etc. The ethics committees at pharmaceutical associations will have the power to issue penalties and other appropriate disciplinary  measures.

As a result of the above measures and other new drug regulations, the number of drug clinical trials in India is growing again after a steep decline from 2013 to 2019. Over the last 5 years the number of drug investigators for clinical trials and number of clinical sites for trials has doubled. In addition, more participants in India are feeling comfortable to participate in Indian clinical trials and the time to finish Indian clinical trials have been reduced. More Western drug companies are now looking to increase their drug clinical trials in India.

In short, the Indian drug market is back. Further regulatory changes will continue to make this an attractive drug market for finished products, drug substances, clinical trials, etc.