India’s drug regulatory body is planning several major changes to make its work easier and more efficient. The reforms are intended to ease the workload of the agency's small team, which is responsible for overseeing the country's massive drug industry. The agency, led by Rajeev Raghuvanshi, has only 2,000 officials to manage over 10,000 drug factories and 1 million pharmacies across the country.

Streamlining export clearances

One of the major reforms in the agency's plans is to simplify the export approval process. Currently, the process involves a detailed review of each drug export application, which can take time. To facilitate this, the agency intends to consider a company's previous export history while granting approval. For example, if a company exported 100 million paracetamol tablets last year, it can get a blanket No Objection Certificate (NOC) to export the same amount this year. This will reduce the number of NOCs required by the agency to issue. The new regime will cover approved exports but not drugs intended for the domestic market. With this change, the regulator expects the number of NOCs issued to be halved from the 10,000 NOCs issued in the last eight months.

Improving manufacturing licenses and research

Another change involves simplifying the process of obtaining a manufacturing license for certain drugs. The CDSCO registration process for research and development of new drugs will be less complicated. It will encourage innovation and make it easier to get approval for drugs used in testing, testing and analysis. These changes are aimed at streamlining and speeding up the overall manufacturing process, which will help drug manufacturers focus more on producing quality drugs.

Investing in digital systems

To better regulate the growing drug industry, the regulator is investing Rs 100 crore (about $11.5 million) to build a new digital drug regulatory system. The system will store all relevant data in one place, including information about manufacturers and their supply chains. Keeping all this information in one database will help the regulator improve efficiency, reduce errors and make decision-making faster and more accurate.

Focus on quality and safety

The regulatory body is also working on new guidelines for emerging areas in the pharmaceutical industry. For example, the agency is developing rules for cell and gene therapies, which are advanced treatments used in health care. The guidelines are expected to be released within two months. Additionally, the agency is updating guidelines for biosimilars to ensure they meet global safety and quality standards. The changes come after some concerns over the safety of Indian-made medicines like cough syrup linked to child deaths in countries like Gambia, Uzbekistan and Cameroon.

By making these changes, India's drug regulator aims to strengthen the country's reputation as the "pharmacy of the world" by ensuring the safety and quality of medicines for both the domestic and international markets.