DCGI boosting India’s Drug Exports
Overview
The Drugs Controller General of India (DCGI) has announced a revamp of the no-objection certificate (NOC) issuance process for exporting unapproved medications in an effort to streamline export procedures and improve regulatory efficiency.
Streamlining Drug Exports
Previously, each time they received an order, companies that exported drugs from India had to file for a NOC that was particular to the customer and quantity.
As long as the medication is authorized in the importing nation, the DCGI will issue a blanket NOC under the new approach based on a company’s exporting history during the previous 12 months. The number of NOCs issued will drop from about 15,000 per year to 5,000 or less since the NOC would be product- and country-specific rather than related to the client or importer. Exporters will have less procedural burden as a result of the move.
DCGI thrives on streamlining procedures while maintaining adherence to regulations. Instead of submitting several applications, businesses now only need to provide their client information and proof of regulatory permission once a year. It is anticipated that this action will preserve regulatory monitoring while streamlining the export procedure.
According to the DCGI, updated biosimilar guidelines will be published shortly. The new framework, which was last updated in 2018, attempts to bring Indian legislation into compliance with the most recent international norms.
CDSO to enhance oversight
To lessen the strain on its workforce, India’s pharmaceuticals regulator plans to enact a number of reforms, such as expediting export clearances for unapproved medications and streamlining the manufacturing licensing procedure. The Department of Biotechnology (DBT) and the Indian Council of Medical Research (ICMR) have directed the Central Drugs Standard Control Organization (CDSCO) to establish its first regulatory guidelines for cell and gene therapy.
Additionally, the CDSCO has stepped up its inspections; in the last two years, roughly 905 have been finished. The agency is keeping a careful eye on businesses that have been granted NOCs in order to assure compliance in light of recent incidents, such as the recent Aveo case. The DCGI emphasized the need for India to increase its support in response to worries about regulatory control in export markets, especially in low- and middle-income countries (LMICs).
Rs. 100 Cr. Digital Regulatory Infrastructure
DCGI also described the development of a ₹100 crore digital regulatory infrastructure that will combine manufacturers, customs, state regulators, and GST into a one database. This platform will chart the supply chain from permission to sale and is scheduled to go live in two years.
Further the department underlined the necessity of increasing CDSCO’s internal scientific competence by establishing roles for reviewers and evaluators in order to lessen the organization’s dependency on subject expert committees (SECs). These initiatives show a dedication to enhancing and modernizing India’s drug laws.
Conclusion
The DCGI is boosting India’s pharmaceutical exports by expediting NOC issuance, lowering exporter burdens, and implementing blanket NOCs. A ₹100 crore digital platform and capacity-building efforts aim to modernize rules, improve efficiency, and boost global competitiveness.
The image added is for representation purposes only
