A Kick-Start For Pharma Exports

The national regulatory body for Indian pharmaceuticals clears the way for exporters by doing away with the No-Objection Certificate for consignments meant for foreign markets.

India’s pharma exporters received a bonus recently when the government-controlled Central Drugs Standard Control Organisation (CDSCO is the national regulatory body for Indian pharmaceuticals and medical devices and is similar to the Food and Drug Administration of the United States) ordered that pharma exports did not need any clearance from drug regulatory authority. Incidentally, pharma exports to the US, Canada, Japan, Australia and European Union did not need a No-Objection Certificate (NOC) for export consignments, Now, however, the Drug Controller General of India (DCGI) has included all countries in the rule. There was a rider, though: the NOC would not be needed if the shipping bills were filed by the manufacturer with a valid licence under the Drugs and Cosmetics Act and Rules.

The order, a part of the government’s ease of doing business, also mentioned that the move had been taken to simplify regulations for exports of drugs, medical devices and cosmetics. “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 mentioned.

The order came at a crucial juncture: the country’s pharma exports totalled $16.8 bn in 2016-17, according to figures put out by the Pharmaceuticals Export Promotion Council. Pharma exports are slated to grow by 30 percent to reach $20 bn by 2020.