Pharma exports do not need regulator’s approval, Govt tells companies
All pharma exports can continue without a no-objection certificates (NOC) from the regulatory authorities, according to a CDSCO notice
New Delhi: Pharmaceutical companies will no longer have to obtain a drug regulatory clearance for exporting drugs and medical devices, the government said on Wednesday in a step aimed at making it easier to do business.
According to a notice put out on Wednesday by the Central Drugs Standard Control Organisation (CDSCO), all pharma exporters can continue exporting without having to obtain no-objection certificates (NOC) from the regulatory authorities.
While this facility was earlier available only for pharma exports to the US, Canada, Japan, Australia and European Union, the Drug Controller General of India (DCGI), S. Eswara Reddy, has now decided to extend the rule to all other countries.
“The NOC for export consignments to any other countries shall not be insisted (upon), if such bills are filed by the manufacturer himself, having valid license under the Drugs and Cosmetics Act and rules,” said the notice posted on the CDSCO website.
“This is being done to bring ease in the drug regulatory practices in India relating to export of drugs, medical devices and cosmetics. All the stakeholders are however required to comply with the regulatory requirements of the importing countries as per their specific needs,” the DCGI notice added.
India’s pharma exports stood at $16.8 billion in 2016-17 and are expected to grow by 30% to reach $20 billion by 2020, according to the Pharmaceuticals Export Promotion Council of India.
D.G. Shah, secretary general of the Indian Pharmaceutical Alliance, which represents large domestic drug makers, said the move is expected to reduce “unnecessary paperwork” and “corruption”.
“It’s part of ease of doing business for the manufacturers exporting their products to other countries. The move will encourage hassle-free exports to other countries. Even when the manufacturers were obtaining NOC from the CDSCO, the regulatory authorities were not responsible for the quality of the products. So obtaining NOC was only adding to the paperwork and corruption. This move will help end malpractices and unnecessary delay,” Shah added.
Calling it a remarkable step for ensuring ease of doing business, Rajiv Nath, Forum coordinator, Association of Indian Medical Device Industry said, “Such measures will help instill confidence in manufacturers in the regulatory framework and the implementing agency CDSCO as being responsive to the genuine needs of licensed manufacturers exporters.”
“The needless two-three day delay of export shipments acting as a non tariff barrier and a competitive disadvantage of Indian Medical Devices exporters has been done away with. We had to listen to complaints from our buyers of shipment delays and lengthier delivery period for emergency supplies by expensive airfreight compared to competing suppliers in China and Taiwan etc,” he said.