Govt allows imported drugs with residual shelf life of under 60%

Relaxes norms as cargo stuck at ports makes it difficult for consignments to be released expeditiously, subject to written request from importer

With containers stuck in transit for days together, the Indian government has decided to allow some relaxation on the import of drugs. Under the existing rule, imported drugs that have less than 60 per cent shelf life remaining are not allowed into the country. However, given the supply chain disruption this rule has been relaxed by the Central Drugs Standard and Control Organisation (CDSCO). 

In a notification dated April 17, the Directorate General of Health Services (DGHS) said that under exceptional conditions the licensing authority may allow import of drugs with lower shelf lives, provided that the expiry date has not been reached. The reasons, however, have to be recorded in writing. 

The lack of truck drivers amid the lockdown has had several thousands of tonnes of cargo, including essentials, stuck at various ports across the country. Reports in the first week of April suggested nearly 40,000 containers were stuck at Chennai and container freight stations (CFS). 

India is not a large pharmaceutical formulation importer and depends on China for active pharmaceutical ingredients (APIs) or raw material to make drugs. 

According to rough estimates, India imported pharmaceutical products worth $1.7 billion in 2019. Most of this was bulk drugs from China. "India imports bulk drugs and some vaccines. Importers were finding it difficult to comply with the condition that imported medicines should have more than 60 per cent shelf life as some of the consignments are stuck in ports not just for weeks, but for months. Moreover, any consignment coming China especially is quarantined for some weeks," said a senior official in an industry association. 

The DGHS move comes in the wake of the health ministry directive to all departments to take steps to ensure that drugs were available in sufficient quantity in the domestic market. One of the steps taken by the ministry is to issue immediate approvals to applications for registration, import and manufacture of pharmaceuticals. 

Further, after industry associations raised concern that due to the Covid-19 crisis there are challenges in clearances at port offices and many products are losing shelf life and getting below the threshhold of 60 per cent, the government took the call. 

Welcoming the move, Sudarshan Jain, secretary general of the Indian Pharmaceutical Alliance said that the government is taking all steps necessary to iron out the challenges the pharma industry now faces.