DCC: Sub-committee to look into one-time NOC for exports

The DCC has proposed including this concern in the sub-committee's investigation to explore potential relaxation of the destruction clause

The Health Master

April 15, 2024

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Last Updated on September 30, 2024 by The Health Master

DCC

The Indian pharmaceutical industry is a global powerhouse, but navigating export regulations can be a hurdle. The Drugs Consultative Committee (DCC) is taking steps to simplify the process, particularly for unapproved, new drugs intended solely for export.

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One-Time NOC and Manufacturing License: Examining the Possibilities

Industry Request: Pharmaceutical companies have requested a one-time export NOC (No Objection Certificate) and manufacturing license, followed by a Certificate of Pharmaceutical Product (CoPP), for unapproved, banned, or new drugs destined for export markets.
DCC’s Consideration: The DCC acknowledges potential benefits for approved and new drugs but expressed reservations about banned drugs due to misuse concerns.
Sub-Committee Formation: To thoroughly assess the pros and cons, the DCC has recommended forming a sub-committee dedicated to this issue.

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Destruction of Unapproved Drugs: Addressing Economic Loss

Current Regulations: As per DCGI (Drugs Controller General of India) guidelines, any unapproved drugs manufactured for export but not shipped must be destroyed.
Industry Concerns: This requirement is seen as an economic burden, leading to wasted resources and lost profits.
Sub-Committee’s Review: The DCC has proposed including this concern in the sub-committee’s investigation to explore potential relaxation of the destruction clause.

Timely Exports: Balancing Efficiency and Control

Industry’s Argument: The current system, requiring repeated applications for NOCs and licenses for each export order, is time-consuming and delays shipments.
Past Practices: Previously, NOCs were obtained centrally from CDSCO before acquiring state-level manufacturing licenses.
Streamlining Efforts: In 2018, the process was decentralized, delegating NOC and license approvals to state authorities for faster turnaround.

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Finding the Right Balance: The Sub-Committee’s Role

The newly formed sub-committee will play a crucial role in:

Evaluating the feasibility of a one-time NOC and manufacturing license system for specific categories of drugs.
Assessing the potential risks and benefits associated with relaxing the destruction clause for unapproved drugs.
Proposing recommendations for optimizing the export approval process while maintaining regulatory control.

Conclusion

The DCC’s initiative demonstrates a commitment to fostering a more efficient export environment for the Indian pharmaceutical industry.

By carefully examining the industry’s requests and potential solutions, the sub-committee’s findings can pave the way for a more streamlined and competitive export landscape.

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