Food and Drugs Administration, Haryana, India. |
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Last Updated on May 6, 2024 by The Health Master
Pseudoephedrine
Here’s a breakdown of key points regarding Pseudoephedrine regulations in India:
1. Controlled Substance: Since March 26, 2013 (notification S.O. 834(E)), Pseudoephedrine is classified as a “Controlled Substance” under the Narcotic Drugs and Psychotropic Substances Act.
2. Schedule A: It’s included in Schedule A of the “Narcotic Drugs and Psychotropic Substances (Regulation of Controlled Substances) Order, 2013.”
3. Manufacturer Registration: Manufacturing Pseudoephedrine (API or formulations) requires mandatory registration with the Narcotics Control Bureau (NCB).
4. Purchase Registration: Buying Pseudoephedrine also necessitates NCB registration and a unique registration number.
5. Quarterly Returns: Manufacturers must submit quarterly reports on Pseudoephedrine to the NCB.
6. No NRx Labelling: Labelling Pseudoephedrine formulations as “NRx” (prescription only) isn’t mandatory.
7. Drug Act Schedule: It’s not classified under Schedules H, H1, G, or X of the Drugs Act, 1940 and its 1945 Rules.
8. Labelling Requirements: Labelling of Pseudoephedrine formulations should adhere to Schedule H of the Drugs Act (1940) and its Rules (1945).
9. Not Narcotic or Psychotropic: Importantly, Pseudoephedrine isn’t defined as a “Narcotic Drug” or “Psychotropic Substance” under the NDPS Act.
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