In a move aimed at simplifying export procedures and enhancing regulatory efficiency, the Drugs Controller General of India (DCGI) announced a major overhaul in the process of granting No Objection Certificates (NOCs) for the export of unapproved drugs.
Previously, companies exporting drugs from India had to apply for a customer- and quantity-specific NOC each time they received an order. Now, under the new system, the DCGI will grant a blanket NOC based on the company’s history of exports of the particular drug over the past year, as long as the drug is approved in the importing country. The NOC will not be tied to the client or importer but will be product- and country-specific, reducing the number of NOCs issued from approximately 15,000 annually to around 5,000 or fewer.
The move is expected to significantly reduce the procedural burden on exporters.
Speaking on the sidelines of the Indian Pharmaceutical Alliance’s (IPA) Global Pharmaceutical Quality Summit 2025, Rajeev Raghuvanshi, DCGI, stated: “We are simplifying the process while ensuring compliance. Now, companies only need to submit details of their customer and proof of regulatory approval once per year instead of making multiple applications.”
This move is expected to significantly streamline the export process while maintaining regulatory oversight.
The DCGI also revealed that revised guidelines for biosimilars will soon be released. The last update was in 2018, and the new framework aims to align Indian regulations with the latest global standards. Additionally, the Central Drugs Standard Control Organisation (CDSCO) is in the process of drafting its first regulatory guidelines for cell and gene therapy, a sector currently governed by directives from the Department of Biotechnology (DBT) and the Indian Council of Medical Research (ICMR).
“We are developing a regulatory framework to guide the approval process for cell and gene therapies, ensuring clarity for applicants and alignment with global best practices,” Raghuvanshi stated.
The CDSCO has also intensified its inspections, with nearly 905 completed in the past two years. Recent events, including the Aveo case, have prompted the agency to closely monitor companies that have received NOCs to ensure compliance.
In response to concerns about regulatory oversight in export markets, particularly in low- and middle-income countries (LMICs), Raghuvanshi emphasised the need for India to strengthen its support. “Many LMICs rely on the regulatory systems of exporting countries ,” he noted. “We must ensure our system is robust to assist them.”
Raghuvanshi also detailed the progress of the ambitious digital regulatory platform, a Rs 100 crore project aimed at integrating all regulatory stakeholders. “This platform will bring together state regulators, partner agencies like customs and GST, and manufacturers, creating a comprehensive database of the entire regulatory value chain,” he said. The platform aims to map the supply chain, from approvals to sales, providing a unified information source and will be operational in the next two years.
Raghuvanshi also addressed the need for internal scientific capacity building within the CDSCO. “We are in the process of creating new positions for evaluators and reviewers,” he said. “Currently, our workforce is primarily trained for executing the law, not for in-depth scientific evaluation.” This initiative aims to reduce reliance on Subject Expert Committees (SECs) for all technical matters.
Raghuvanshi clarified the CDSCO’s stance on SEC deliberations, stating that re-deliberations will only be allowed if new information is presented by a company. “We will not allow companies to repeatedly push the same content to SECs,” he asserted.
He also indicated that changes to test licences, particularly for small-quantity imports for testing and analysis, are under consideration, with further details to be announced in forthcoming regulations.
The DCGI’s announcements signal a concerted effort to modernise and strengthen India’s drug regulatory framework, ensuring both domestic safety and responsible export practices .
The DCGI said that it is reviewing all the NOCs given to Aveo Pharmaceuticals, a pharma exporter under regulatory scrutiny for exporting unapproved drug combinations of tapentadol and carisoprodol. More companies that export similar products may also be reviewed.
Seventy-seven NOCs were granted to the company, all of which have now been cancelled. The DCGI is reviewing the data that the company submitted to the regulator to obtain these NOCs.
The move against Aveo Pharma followed a recent BBC investigation that exposed a racket in which a Mumbai-based producer, Aveo Pharmaceuticals, was exporting the unlicensed addictive combination to West African countries such as Nigeria, Ghana, and Côte d’Ivoire.
The Union health ministry said that Aveo Pharmaceuticals has been issued a Stop Activity Order, halting all operations at the company’s premises after a comprehensive audit by a joint team of the CDSCO and the Maharashtra state regulatory authority.
