In a key step to boost Indian pharmaceutical exports and regain worldwide credibility, the Central Pharmaceuticals Standard Control Organisation (CDSCO) has released new criteria for acquiring Export No Objection Certificates (NOCs) for the production of unapproved, prohibited, or novel pharmaceuticals. This centralised procedure necessitates thorough documentation and legal commitments from producers to ensure strict regulatory supervision.

According to the updated standards, corporations must submit applications on letterhead with an authorized signatory's signature. The application must include a valid manufacturing licence, a list of items for export, and complete drug information, such as quality control testing locations, dosage forms, composition, strengths, and quantities. Furthermore, businesses must present genuine purchase orders or proforma invoices from international buyers. If the trader's name appears on the order, they must enclose a letter with the purchase order number.

The new criteria require a recent, self-attested order that is no more than six months old, as well as a pro forma invoice or purchase order from the importing country that specifies the details and quantities of the pharmaceuticals to be made. To ensure transparency and accountability, it is also necessary to provide reconciliation data for previously approved export volumes.

This move follows CDSCO's decision to centralise the NOC issuance process, eliminating responsibilities formerly given to state and union territory licencing authorities. Manufacturers must now get NOCs from CDSCO zonal offices through the Sugam Portal before applying for production licences from state authorities. This centralised approach attempts to improve regulatory control and streamline the export licencing procedure.

The decision is part of a larger effort to address concerns about the safety and quality of Indian medications, particularly in light of recent events in Ghana and Uzbekistan in which children allegedly died after swallowing cough syrup prepared in India. CDSCO aims to restore global trust in Indian pharmaceutical products by centralising the NOC process and improving documentation standards.

Dr Rajeev Singh Raghuvanshi, the Drugs Controller General (India), emphasised the significance of this endeavour, stating that online application submissions via the Sugam Portal will be required from May 15, 2024. To ensure a smooth transition to the new system, CDSCO zonal offices must receive all previously issued NOCs.

The CDSCO headquarters has selected Ranga Chandrashekar Rao, the Joint Drugs Controller (India), as the nodal officer for issuing NOCs, demonstrating the organisation's commitment to efficient and transparent regulatory processes. This project builds on the Drugs Consultative Committee's (DCC) suggestions to shorten the export NOC and manufacturing licence process, notably for unapproved and novel medications, while excluding banned drugs.

By ensuring that only high-quality, properly verified medicines enter international markets, the new criteria aim to strengthen Indian pharmaceutical exports. This regulatory revamp intends to close the trust gap and confirm India's position as a dependable global supplier of pharmaceuticals.