Pharma lobby flags 'cumbersome' export rule, seeks change

Time of India

7 hours ago

New Delhi: A significant dip in exports has prompted
pharma lobby
groups to raise a demand for changing the centralised no-object certification (NOC) provision for
drug exports
. The provision, which requires pharma companies to seek an approval from the national regulatory agency of the importing country or an NOC from the Indian regulator for shipments, has resulted in a drop in exports and diverted trade to other nations, industry executives told ET. The issue was raised in a meeting held on Monday at
Niti Aayog
.
"Pharma exports have suffered due to the mismatch or an anomaly in newly introduced
regulatory standards
by the drug regulatory authority of India," said a person who attended the meeting.
In early March, the Drugs Controller General of India (DCGI) updated the export NOC checklist in the wake of events such as the controversy over a Mumbai-based drugmaker allegedly exporting addictive opioid drugs to West African nations such as Ghana and Nigeria.
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However, the stringent norms have started hurting exports, industry insiders said.
"Taking approvals from different regulatory bodies has only made the whole process cumbersome," the person cited above said. He noted that medicines are manufactured depending on the patient population construct.
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For example, Dolo and other paracetamol tablets are approved in India in strengths of 325mg, 500 mg and 650 mg while in Nigeria, it's approved for a strength of 1,000 mg. To manufacture and export that, Indian drugmakers now require an NOC from Nigerian authorities.
The lobby groups have urged the government to review the provision as, according to them, this would divert trade to other nations with less stringent regulations.
"Such a condition has imposed an undue burden on Indian exporters, potentially stifling innovation and hindering the export of unapproved/banned products especially for the MSME pharmaceutical sector, which is under tremendous strain with respect to compliance to domestic and international guidelines and trade barriers (tariffs & non-tariffs),' an industry expert said on condition of anonymity.
The Niti Aayog had called pharma experts to undertake an analysis of the current state of the industry, to understand the challenges faced by drugmakers and initiatives taken by them to ensure production of safe and effective products.
Nikkhil K Masurkar, chief executive of Entod Pharmaceuticals, said the official think tank's call for a quality overhaul is both "timely and necessary."
"While India has made remarkable strides as a global pharma hub, maintaining consistent, internationally acceptable quality standards remains a key challenge, especially among MSME companies," he said.
"The root of the problem often lies not in intent, but in outdated infrastructure, fragmented regulatory enforcement, and insufficient technical training," Masurkar said. "To produce world-class medicines, we must invest in continuous quality improvement, digitalise compliance systems, and empower our MSME sector with both financial and technical support."