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.
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.
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.
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.
Disclaimer: This article contains information derived from the source mentioned below. Our team utilized an AI language model to rewrite and present the news or article in a unique format.
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