The Central Drugs Standard Control Organisation (CDSCO) has relaxed the drug regulatory clearance for the pharmaceutical exporters of India to developed countries through wide No.DCGI/MISC/2015 (199) dated on December 11, 2015. According to this notice, all the pharma exporters to advanced developed nations can do their exports without having no-objection certificates (NOC) from the CDSCO starting from January 1, 2016.

“It has been decided that the requirement of 'no-objection certificates' with respect to Shipping Bills from the port offices of the CDSCO for the export consignments to USA, Canada, Japan, Australia and European Union shall not be insisted with effect from January 1, 2016. This is being done in pursuit to bring ease in the drug regulatory practices in India related 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 need,” Drug Controller General of India (DCGI) Dr GN Singh in a notice said.

In a move to encourage hassle-free exports to developed countries like USA, Japan, Canada, Australia and European Union, the CDSCO has relaxed the system of ‘no-objection certificate’ from the government to export their pharmaceutical products to the developed countries.

Having received representation from some of the exporting pharma companies, the CDSCO and department of commerce (DoC) have decided to waive off the condition of compulsory NOC for exporting their products to the foreign countries. “This is a big step by the government in ensuring hassle free exports. Earlier we received a few representations from some of our member companies with regard to issue relating to easing of export procedures. Pharmexcil took it to the CDSCO and DoC and pursued with the concerned officials in the government and could successfully convince them for waiving off the NOC,” said Dr PV Appaji.

With government waiving off the NOC system, it has eased the drug regulatory clearances for all the pharmaceutical exporters exporting their products to developed countries.

With this new development, the central government’s intention to boost the industry’s growth is clearly evident. As promised earlier, the government is taking all necessary steps to boost India’s trade with other countries.

All exporters of drugs, medical devices and cosmetics meant for exporting to countries like USA, Japan, Canada, Australia and Europe can export their consignment without NOC, however they have to oblige the regulatory conditions of safety, quality and others stipulated by the concern importing countries as it is, informed sources from CDSCO.