The Pharmaceuticals Export Promotion Council of India (Pharmexcil) has written a letter to the Directorate General of Foreign Trade (DGFT), an arm of the Ministry of Commerce and Industry, to allow Export Oriented Units (EOUs) to continue the export of the 26 restricted APIs/formulations.
Recently, the Government of India issued a notification banning the export of hydroxychloroquine and formulations made from it. However, it can be exported from units in Special Economic Zones and EOUs.
The notification also mentions that it will be allowed for exports by the Government of India to other countries on humanitarian grounds on case to case basis on the recommendations of the Ministry of External Affairs.
Commenting on the letter written by the Pharmexcil dated 23rd March, and the recent ban on the export of hydroxychloroquine and its formulations, Ravi Uday Bhaskar, Director General Pharmaceuticals Export, (Pharmexcil) said, “Yesterday, we realised that the government has exempted the SEZ and EOUs from the export of hydroxychloroquine and formulations made from it. However, we are unable to understand why the EOUs have not been taken into consideration, which were restricted in the Notification 50, stating restriction on the exports of 26 APIs/formulations.”
He also mentioned that due to that notification other medicines, which are not part of the export restrictions have also got stuck at different ports across the country.
The Pharmexcil’s letter to DGFT for EOU significantly highlights that drugs manufactured by EOUs are not as per the Indian Pharmacopeia (IP) specification (the basic and major regulatory requirement to sell the drugs in India). These drugs cannot be utilised for domestic sale as per the law currently prevailing. Thus, the restrictions on exports of listed drugs are causing the loss of shelf life of the manufactured goods by the EOUs which is then leading to the wastage of the drugs without serving the prime objective of the notification.
After Pharmexcil’s letter to the DGFT on March 23 was issued, Dr Dinesh Dua, Chairman, Pharmexcil followed up with the authority and informed, “We reiterate that the notification had created a lot of inconvenience and hardships to our exporters, which had impacted the pharma export performance of the nation, whereas in the case of hydroxychloroquine and it’s formulation Chloroquine, it has been already done. Pharmexcil strongly recommends that the consignment of 26 molecules, which are lying at different ports across the country, should be allowed for the export. Their demurrage is being paid by the exporters, besides their inability to meet their commitment to the importing countries. Similarly, there is some material which has been packed with these molecules, ready to be dispatched in the fully packaged form. However, the situation is very vital in the case of the vitamins, which are not used in the treatment of Covid-19. In contrast, molecules (restricted 26 APIs and formulations) produced in Hubei province and some part of the Wuhan city are now being dispatched, right from an epicentre of Covid-19, as the situation has come under control relatively in China.”
Mahesh Doshi, President, Indian Drugs Manufacturers Association (IDMA) said, “As requested by the Secretary and the Joint Secretary of the Ministry of Health and Family Welfare to give an understanding of maintaining four months stock of the restricted medicines in the country in the crucial time of coronavirus outbreak, we have submitted the requested data, and are waiting to hear from them.”
u.sharma@expressindia.com