Following export curbs on 26 drugs and active pharmaceutical ingredients (APIs) used in formulations, the Pharmaceuticals Export Promotion Council of India (Pharmexcil) under the commerce ministry has sought amendments to the export policy, thus allowing free export of drugs manufactured before March 3, 2020, and for goods lying at ports. Most of these drugs such as vitamins and hormones have limited shelf life of 18-24 months and if the restrictions prolong, buyers will not accept the product and the same formulations cannot be utilised for domestic consumption.
In a letter to the directorate general of foreign trade, the pharma body requested for examining the feasibility of exempting those labelled “drugs manufactured for export purpose only” from the restrictions. “Most of the manufacturers and exporters have manufactured these listed items before the outbreak of COVID-19, and have planned and committed to ship the consignments to customers in agreed timelines. The reference notification imposing restriction on export of the listed items with immediate effect would severely impact our members, as many number of consignments are already lined up for export in the warehouses and ports,” a Pharmexcil letter said.
Udaya Bhaskar, director-general, Pharmexcil, “Some of the orders for institutional supplies mandate the supply of all items committed in their contracts and non-supply of one item would result sometimes in cancellation of entire order for all other products resulting in blacklisting of the companies by the procurement agencies and imposes huge penalties.”
As a result, he said the exporters not only suffered the monetary losses but also their credibility and reputation were at stake. He also added they might also face some legal issues with the buyers as per their contractual agreements.
He said, “We worry that the image of our country as ‘pharmacy of the world’ would have a dent as a result of this sudden restriction on exports.” He added the pharma body also would like to submit that formulations for domestic sale should comply with intellectual property specification according to the regulatory requirements of the National Regulatory Authority.
In addition, the formulations manufactured for exports as per the specific countries requirements (pharmacopoeia specifications/labels/printing material used) cannot be diverted or utilised in domestic market.
