Mumbai: In a bid to ensure ease of doing business and facilitate exports, the health ministry has relaxed guidelines for pharmaceutical and medical device manufacturers. Licensed manufacturers of drugs, medical devices and cosmetics will no longer need to procure a ‘no-objection’ certificate (NOC) from drug regulatory authorities for export consignments across 15 ports in the country.
Pharmaceutical exports from India are estimated over Rs 1 lakh crore annually. At present, drug, medical device and cosmetic consignments face unnecessary hurdles and huge delays at ports over the NOC requirement, in addition to customs documentation. As a result, ports get congested and most consignments are held up — sometimes for weeks.
In a decision on Wednesday, the Central Drugs Standard Control Organisation (CDSCO) said the NOC for licensed manufacturers will be waived, if ‘shipping bills’ submitted by the company includes a copy of the manufacturer’s licence. The decision to facilitate exports to certain markets — including the US, Canada, Japan, Australia, European Union — was taken a few years back. Now, this has been extended to exports to any country across the world, the circular issued by the regulatory authority said.
“To promote and facilitate export of pharmaceuticals from India, CDSCO has taken various measures including waiver of NOC from its port offices. All stakeholders are however required to comply with regulatory requirement of importing countries, according to their specific needs,” Dr S Eswara Reddy, drugs controller general of India told TOI. However, this waiver will not be applicable for traders, who do not possess a manufacturer’s licence as they are not manufacturing the drug.
Rajiv Nath, forum coordinator, AiMeD — an industry body representing medical device companies, said, “An excellent step taken for ensuring ease of doing business. Such measures will help instil confidence in manufacturers of the regulatory framework and the implementation agency CDSCO as being responsive to 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.”