New Delhi, Mar 10 (KNN) The Pharmaceuticals Export Promotion Council (Pharmexcil) has formally requested a review of recently implemented regulations requiring product registration certificates from importing countries’ regulatory agencies or approval from Indian regulators for drug export clearance.
This appeal comes amid concerns that the new requirements could severely impact India’s pharmaceutical export industry.
Raja Bhanu, Director-General, Pharmexcil, which operates under the Ministry of Commerce & Industry, warned that the amendment could significantly burden India’s pharmaceutical export sector.
In his recent letter to the Drugs Controller General of India (DCGI), Bhanu cautioned that the stricter regulations might redirect trade to countries with more lenient regulatory frameworks and potentially encourage illicit transactions.
The DCGI’s update to the export No-Objection Certificate (NOC) checklist follows recent controversies, including allegations against a Mumbai-based company regarding the export of potentially addictive opioid drugs to West African nations such as Ghana and Nigeria.
While acknowledging the industry’s willingness to cooperate with regulators to prevent unauthorised movement of psychotropic substances, Bhanu expressed ‘serious concerns’ about the practicality of the new rule.
Currently, pharmaceutical exports from India proceed after companies obtain NOCs from either the Central Drugs Standard Control Organisation (CDSCO), India’s national regulatory body for pharmaceuticals, cosmetics, and medical devices, or from state licensing authorities.
The implementation of additional requirements would create significant challenges for exporters, according to Pharmexcil.
Bhanu explained that export NOCs are primarily needed for new drugs or formulations that are unapproved or banned in India but approved for marketing in other countries.
He emphasised that requiring approval documentation from foreign regulatory agencies would be exceedingly difficult due to the complexities of global regulatory frameworks and varying levels of regulatory maturity worldwide.
The Pharmexcil chief argued that such conditions would place undue burden on Indian exporters, potentially stifling innovation and hindering exports, especially for the MSME pharmaceutical sector already struggling with domestic and international compliance requirements and trade barriers.
He suggested that enforcing other sovereign countries’ regulatory requirements as prerequisites for issuing export NOCs appears to contradict free trade principles, except for substances explicitly prohibited under universally recognised international norms.
Bhanu further noted that all pharmaceutical exports already undergo regulatory scrutiny at ports of entry and are only released after confirmation that the products are approved for use in the importing country.
He warned that the new rule could potentially damage the image and credibility of India’s pharmaceutical sector and shouldn’t be implemented based on ‘one odd or sporadic incident.’
(KNN Bureau)
