New Rule for Drug Exports and Industry Concerns

Amendment Details

The Pharmaceuticals Export Promotion Council (Pharmexcil) has expressed concerns over a new rule requiring a product registration certificate from the national regulatory agency of the importing country or approval from the Indian regulator to issue a no-objection certificate (NOC) for drug exports. This rule could significantly impact India's pharmaceutical export sector.

Potential Implications

• Divert trade to countries with less stringent regulations.
• Increase illicit and clandestine dealings.
• Strain on the pharmaceutical sector, reducing competitiveness.

Context and Recent Developments

The rule change follows incidents like the controversy involving a Mumbai-based company's export of addictive opioid drugs to West African nations. The Director-General of Pharmexcil, Raja Bhanu, has raised these concerns in a letter to the Drugs Controller General of India (DCGI), emphasizing the industry's willingness to curb unauthorized movements of psychotropic substances.

Current Export Approval Process

Pharmaceutical exports currently require NOCs from the Central Drugs Standard Control Organisation (CDSCO) or state licensing authorities.

Challenges with the New Rule

• The rule applies to new drugs or those unapproved/banned in India but approved elsewhere.
• Global regulatory complexities make compliance challenging.
• Undue burden on exporters, particularly affecting MSMEs.

Potential Consequences

• Stifling innovation and hindering exports.
• Contradicting principles of free trade unless prohibited under international norms like NDPS.
• Regulatory scrutiny at the port of entry in importing countries ensures product approval.

Conclusion

Pharmexcil warns that the rule could damage the Indian pharma sector's image and credibility. It emphasizes that the rule shouldn't be based on isolated incidents.