The Centre has recently allowed the export of medicinal products made from Paracetamol, although the restriction on exporting Paracetamol Active Pharmaceutical Ingredients (APIs) remains in place. APIs are crucial components of drugs responsible for producing the intended effects. The decision follows the recent approval for the shipment of the antimalarial drug, Hydroxychloroquine (HCQ), to the United States and other countries.
Paracetamol and Related Formulations
In early March 2020, the Directorate General of Foreign Trade (DGFT) listed Paracetamol and its related formulations as some of the 13 APIs and their formulations on the news bulletin. These formulations, also including Fixed Dose Combinations (FDCs) that are classified under any ITCHS code, are now freely exportable. Notably, two or more drugs combined in a single dosage form, such as a tablet or capsule, are identified as an FDC. Atripla, an HIV medication, is a common example of an FDC, combining efavirenz, emtricitabine, and tenofovir disoproxil fumarate. The careful structuring of FDCs can improve adherence to treatment regimens for conditions such as HIV by reducing daily pill intake.
ITCHS Codes and Indian Trade Clarification
ITCHS codes, more conventionally known as Indian Trade Clarification (ITC), are founded on the Harmonized System (HS) of Coding which has been adopted in India to streamline import-export operations. Indian customs use an eight-digit ITC (HS) code tailored to match national trade requirements.
Pharmaceutical Export Promotion Council of India
The Pharmaceutical Export Promotion Council (Pharmexcil) of India has been vocal in requesting the Centre to also resume the export of Paracetamol APIs. The Ministry of Commerce and Industry, Government of India, established Pharmexcil in 2004 with the objective of boosting pharma exports.
Global Importance of Paracetamol
A widely used fever medication globally, Paracetamol has become increasingly sought after during the Covid-19 pandemic. India is recognized as one of the leading manufacturers of Paracetamol worldwide, with the capability to produce an estimated 5,000 tonnes a month. In an export context, Paracetamol is considered a low-value, high-volume product.
Role of the Directorate General of Foreign Trade
The DGFT serves as the primary governing body concerning matters related to the Exim (Export-Import) Policy. It operates under the Ministry of Commerce and Industry with its key responsibility being the development and regulation of foreign trade. This role involves facilitating imports into India and enhancing India’s export. The DGFT operates under the Foreign Trade (Development and Regulation) Act, 1992, which replaced the previous Imports and Exports (Control) Act 1947.
