CDSCO Centralizes Power for Issuing NOC Solely for Export of Unapproved, Banned, & New Drugs

Under the new directive, all manufacturers are mandated to secure NOCs from the respective zonal offices of CDSCO through online channels, utilizing the Sugam Portal. 

In a significant move, the Central Drugs Standard Control Organisation (CDSCO) has revamped its process for issuing No Objection Certificates (NOCs) exclusively to export unapproved, banned, or new drugs. 

The decision entails centralizing the power previously delegated to State and Union Territory Licensing Authorities, marking a pivotal shift in regulatory dynamics within the pharmaceutical sector.

Under the new directive, all manufacturers are mandated to secure NOCs from the respective zonal offices of CDSCO through online channels, utilizing the Sugam Portal. 

Effective from May 15, this procedural alteration necessitates obtaining NOCs before acquiring manufacturing licenses from State Licensing Authorities (SLAs). 

Commenting on the change, Dr Rajeev Singh Raghuvanshi, DCGI, said, "The decision to withdraw powers delegated to State/UT Licensing Authorities underscores a centralized approach to streamline the issuance process."

This development aligns with a directive issued by the Union Health Ministry to the DCGI on June 21, 2023, urging the facilitation of fresh applications through online platforms starting mid-May 2024. 

Deliberations on Export NOC Relaxations

The decision to centralize NOC issuance stems from a broader examination of industry demands and regulatory efficacy. 

Acknowledging the need for enhanced industry facilitation, the Ministry endorsed a proposal to transition NOC application processes to a single designated point of contact within CDSCO headquarters. 

This reconfiguration seeks to expedite application processing while ensuring regulatory compliance.

Furthermore, the Drugs Consultative Committee (DCC) convened to deliberate on industry requests for one-time export NOC and manufacturing license concessions for select categories of drugs. 

Notably, the committee also noted the importance of delineating between approved and unapproved drugs, recommending cautious consideration of relaxation measures. 

Reflecting on these discussions, the DCC iterated, "Grant of one-time export NOC may be deemed viable for certain categories of drugs, with due consideration for regulatory safeguards."

The DCC also deliberated on industry pleas for relaxation of NOC conditions about excess drug quantities. The committee recognized the economic implications and the need to balance regulatory compliance and industry viability. 

"The committee is cognisant of the economic ramifications and is committed to exploring pragmatic solutions," affirmed a DCC spokesperson.

The overhaul in NOC issuance procedures signifies a concerted effort to adapt regulatory frameworks to evolving industry dynamics. 

With this move, the regulatory bodies aim to enhance efficiency and transparency by centralizing authority and embracing online modalities while ensuring adherence to stringent quality standards.

Recent Regulatory Framework  Developments

CDSCO recently released a draft guidance document on stability studies concerning In-vitro Diagnostic Medical Devices (IVDMD).

According to the drug regulator, adherence to this guidance is essential for manufacturers submitting applications for premarket licensing and post-approval changes.

Additionally, in a recent move towards enhancing the regulatory framework, the CDSCO unveiled a revised Guidance for Industry Version 1.2 draft to streamline clinical trial applications and new drug approvals. 

The draft guidance addresses key aspects related to submitting clinical trial applications, requirements for new drug approvals, and preparing quality information for drug submissions, focusing on biotechnological and biological products.

The centralization of NOC issuance for the export of unapproved, banned, and new drugs marks a paradigm shift in regulatory governance within the pharmaceutical domain. 

As stakeholders navigate these regulatory reforms, the emphasis remains on fostering a conducive environment for industry growth while safeguarding public health interests.