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22/03/2018 01:37pm

Pharmaceutical can exports pharma products without obtaining NOC from regulatory authorities: CDSCO

image Pharmaceutical can exports pharma products without obtaining NOC from regulatory authorities: CDSCO

New Delhi, Mar 22 (KNN) With an aim to further improve ease of doing business, government of India announced that all pharmaceutical companies can exports drugs and medical devices without obtaining any sort of clearance from drug regulatory authority.

In a notice issued by the Central Drugs Standard Control Organization (CDSCO), it has been clearly mentioned that without obtaining no-objection certificate (NOC) from regulatory authorities, all pharma exporters can exports anywhere within or outside India without any imposed conditionality.

Earlier this facility was available only for pharma exports to the US, Canada, Japan, Australia and European Union, but now the Drug Controller General of India (DCGI) has passed the rule for all other countries as well.

In a notice released on the CDSCO website, the concerned authority clearly stated that “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.”

The notice further mentioned that this step has been taken in order to bring ease in drug regulatory practices in India relating to exports 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.

According to the Pharmaceuticals Export Promotion Council, India’s pharma exports in 2016-17 stood at $16.8 billion and with this move, it is expected to grow by 30% to reach $20 billion by 2020.

D.G. Shah, secretary general of the Indian Pharmaceutical Alliance, which represents large domestic drug makers, said that this move has been taken to reduce unnecessary paperwork, corruption, un-necessary delays and illegal practices.

Aiming towards ease of doing business, he said that this move will encourage hassle-free exports to other countries.

Though, despite of obtaining NOC from the CDSCO, it did not guarantee any sort of product quality but only adding paperwork and corrupt practices, he 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 manufacturer’s exporters.”

He further added that this move has washed away the earlier practice of obtaining NOC that act as a Non tariff barrier and a competitive disadvantage for Indian Medical Devices exports.

Continuous complaints of buyers related to shipment delays and lengthier delivery period for emergency supplies by expensive air-freight as compared to competing suppliers in China and Taiwan, have forced the authorities to take step in this direction, he added. (With Inputs from a media report) (KNN/YV)

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