Export Curbs on Paracetamol Formulations Removed | 18 Apr 2020

Why in News

The Centre has permitted the export of formulations (medicinal products) made from Paracetamol. However, the restriction on export of Paracetamol Active Pharmaceutical Ingredients (APIs) will continue.

  • The API is the part of any drug that produces the intended effects.

Key Points

  • Paracetamol and its formulations were among the 13 APIs and their formulations that figured in the March 3,2020 notification by the Directorate General of Foreign Trade (DGFT).
  • The formulations made from Paracetamol, including FDC (Fixed Dose Combinations), under any ITCHS code have been made free for export with immediate effect.
    • FDC: Two or more drugs contained in a single dosage form, such as a capsule or tablet.
      • An example of a FDC HIV drug is Atripla (a combination of efavirenz, emtricitabine, and tenofovir disoproxil fumarate). By reducing the number of pills a person must take each day, fixed-dose combination drugs can help improve adherence to an HIV treatment regimen.
    • ITCHS codes are better known as Indian Trade Clarification (ITC) and are based on the Harmonized System (HS) of Coding.
      • These were adopted in India for import-export operations.
      • Indian custom uses an eight digit ITC (HS) code to suit the national trade requirements.
  • The decision allowing export of formulations made from Paracetamol has come after permitting shipment of antimalarial drug Hydroxychloroquine (HCQ) to the United States (US) and several other countries.
  • The Pharmaceutical Export Promotion Council (Pharmexcil) of India wanted the Centre to resume export of Paracetamol APIs too.
    • The Pharmaexcil was established in 2004 by the Ministry of Commerce and Industry, Government of India, to promote pharma exports.

Paracetamol

  • Paracetamol is a common fever medication globally.
  • Paracetamol is the most sought after and widely used drug ever since the Covid-19 outbreak.
  • According to sources, India is among the leading manufacturers of Paracetamol globally.
    • The production capacity is estimated to be 5,000 tonnes a month.
  • From an export perspective, it is a low value, high volume product.

Directorate General of Foreign Trade

  • DGFT is the main governing body in matters related to Exim (Export-Import) Policy.
  • It is an attached office of the Ministry of Commerce and Industry
  • The main objective of it under the Foreign Trade (Development and Regulation) Act, 1992 is to provide the development and regulation of foreign trade by facilitating imports into, and augmenting exports from India.
    • Foreign Trade Act has replaced the earlier law known as the Imports and Exports (Control) Act 1947.

Source: TH