Government Lifts Export Restrictions On Formulations Made From Paracetamol

The government on April 17 lifted restrictions on exports of formulations made from Paracetamol amid the COVID-19 outbreak. With the latest notification, only Paracetamol continued to be 'Restricted' for export.

In a notification, the Directorate General of Foreign Trade (DGFT), an arm of the Ministry of Commerce and Industry said that the restrictions on exports of Paracetamol active pharmaceutical ingredients (APIs) will continue.

"The formulations made from Paracetamol (including fixed-dose combinations)...are made free for export with immediate effect. However, Paracetamol APIs will remain restricted for export," it said.

Amendments On April 6

Barring Paracetamol and formulations made from it, the DGFT had on April 6 allowed export of the 12 APIs and formulations made from them. However, Paracetamol, Hydroxychloroquine, will be only allowed on a license basis. Also, Ritonavir and Lopinavir remained on the restricted list.

The Foreign Trade (Development & Regulation) Act, 1992 (No. 22 of 1992), amended, Para 1.02 and 2.01 of the Foreign Trade Policy, 2015-20, and the Central Government made amendments in chapters 29 and 30 of the Schedule 2 of the ITCHS Export Policy amending the notification which was issued on March 3, which allowed 12 APIs and its formulations.

According to a report by Express Pharma, Anurag Srivastava, the official spokesperson of the Ministry of External Affairs, released a note informing the media that after having confirmed the availability of medicines for all possible contingencies currently envisaged, these restrictions have been largely lifted.

Notification On March 3

The government had earlier on, March 3 had put export restrictions on 26 pharma ingredients and medicines, including paracetamol.

According to this notification, the export of APIs and formulations made from these APIs under the ITC HS codes were restricted until further notice. ITC (HS) codes are better known as Indian Trade Clarification (ITC) and are based on the Harmonized System (HS) of Coding. It was adopted in India for import-export operations. Indian custom uses an eight-digit ITC (HS) code to suit the national trade requirements.

What Is Paracetamol?

A common fever medication globally, Paracetamol (acetaminophen) is one of the most widely used of all drugs, with a wealth of experience clearly establishing it as the standard antipyretic and analgesic for mild to moderate pain states.

Reportedly, India is among the leading manufacturers of Paracetamol globally. Some of the major producers are Farmson Pharmaceuticals, Granules, Sri Krishna Pharma and Bharat Chemicals.

The production capacity is estimated to be 5,000 tonnes a month. From an export perspective, it is a low value, high volume product.

First used clinically by von Mering in 1893, paracetamol did not appear commercially until 1950 in the United States and 1956 in Australia.

Paracetamol is now the first-line choice for pain management and antipyresis in a variety of patients, including children, pregnant women, the elderly, those with osteoarthritis, simple headaches, and those with noninflammatory musculoskeletal conditions.

With judicious use, paracetamol rarely causes adverse events and reports of serious side effects are few.

Hydroxychloroquine Allowed Overseas

According to a report by The Hindu, the decision allowing the export of formulations made from Paracetamol occurred following another permitting shipment of anti-malarial drug Hydroxychroloquine (HCQ) to the US and several other countries.

US President Donald Trump had called Prime Minister Narendra Modi asking for the release of the HCQ orders placed by the US, something India subsequently agreed to. Since then, India has reportedly permitted export to a few more countries as well.

Reportedly, the Pharmaceutical Export Promotion Council of India wanted the Centre to resume export of Paracetamol APIs too.

Pharmexcil Director-General Ravi Uday Bhaskar had earlier requested the DGFT to sanction the export of Paracetamol API and formulations that were produced prior to March 3 and stocked for shipment at the ports.

He welcomed the decision made on April 17 and added that Pharmexcil will renew its appeal on the APIs to the DGFT.

Also Read: Maharashtra: Journalist Assaulted For Publishing Report About Home Quarantined Families