Mumbai
In a bid to enhance its regulatory capabilities, the Drugs Controller General of India (DCGI) is planning to optimize specific export processes. This includes moving from a customer-focused certification system to a quantity-based model.
Currently, the system issues No Objection Certificates (NOCs) for the export of unapproved medications to individual customers or companies, as explained by DCGI head Dr. Rajeev Raghuvanshi. Under the proposed changes, a single NOC would suffice for larger quantities, allowing exporters to submit relevant details to the authorities themselves. This adjustment is expected to relieve regulatory officers from routine administrative tasks, enabling them to focus on value-added activities. It’s important to note that these medications still require prior approvals from the importing country.
This overhaul could potentially reduce the number of NOCs from approximately 15,000 to 5,000, according to Raghuvanshi. Additionally, the DCGI aims to cut the number of licensing tests required for analytical products in half.
Currently, there are around 2,000 regulators overseeing a vast network of 10,000 manufacturing plants, 1 million sales outlets, and about 4,000 medical device manufacturers. Raghuvanshi emphasized the need for more effective regulatory efforts and a shift towards a model that prioritizes execution over excessive regulation.
This announcement was made during the Quality Summit organized by the Indian Pharmaceutical Alliance, which represents major domestic drug manufacturers. The export-related changes come in light of concerns surrounding the alleged misuse of a combination drug produced by Indian company Aveo Pharma in certain West African nations. While investigations continue, it was noted that approximately 77 NOCs had previously been issued for this particular product.
Raghuvanshi highlighted the challenges faced by the regulatory system in balancing the best and worst practices globally. He urged larger pharmaceutical companies to support their smaller counterparts in improving quality standards. Approximately 60% of medicines are produced by small and medium enterprises for larger firms, and he called for increased accountability to maintain high-quality practices. He echoed a recent statement by Commerce Minister Piyush Goyal, encouraging the industry to identify and address bad actors.
Future policy initiatives include establishing guidelines for biosimilar products as well as for cell and gene therapies, an area where many Indian companies are actively engaging, with several already receiving regulatory approval.
The drug regulator also announced plans for a digital regulatory database—a project estimated to cost around ₹100 crore—which is expected to be operational within the next couple of years.
