The Pharmaceuticals Export Promotion Council (Pharmexcil) has voiced strong concerns about a new rule that mandates a product registration certificate from the national regulatory agency of the importing country or approval from the Indian regulator to obtain a no-objection certificate (NOC) for drug exports. This regulation could severely impact India’s pharmaceutical export industry.
Possible Ramifications of the Rule
This new requirement may lead to:
- A shift in trade to countries with more lenient regulations.
- An increase in illicit and unregulated drug exports.
- A decline in the competitiveness of India’s pharmaceutical sector.
Background and Industry Response
The rule change comes in the wake of incidents such as the controversy involving a Mumbai-based company’s export of addictive opioid drugs to West African nations. In response, Pharmexcil’s Director-General, Raja Bhanu, has written to the Drugs Controller General of India (DCGI), highlighting the industry’s commitment to preventing unauthorized exports of psychotropic substances.
Current Export Approval Process
At present, pharmaceutical exporters must secure NOCs from either the Central Drugs Standard Control Organisation (CDSCO) or state licensing authorities before proceeding with shipments.
Challenges Posed by the New Regulation
The regulation specifically applies to new drugs or those that are unapproved or banned in India but authorized elsewhere. However, exporters face several hurdles:
- Complex global regulatory frameworks make compliance difficult.
- The rule places an excessive burden on exporters, especially MSMEs.
- Additional red tape could delay shipments and reduce market competitiveness.
Potential Consequences
If implemented as it stands, the rule could:
- Stifle innovation and hinder pharmaceutical exports.
- Contradict the principles of free trade unless international norms, such as the Narcotic Drugs and Psychotropic Substances (NDPS) Act, explicitly prohibit such exports.
- Be redundant, as importing countries already regulate drug approvals at the port of entry.
Pharmexcil’s Warning
Pharmexcil cautions that the new rule could tarnish India’s reputation as a reliable pharmaceutical exporter. As reported by visionias.in, the organization urges regulators to avoid policy decisions based on isolated incidents and instead adopt a balanced approach that safeguards both trade and public health.
