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The Indian Drug Manufacturers’ Association (IDMA) has made a representation to Narcotics Commissioner, Gwalior regarding preparations/formulations of ergotamine, ergometrine and its salts which are not notified as controlled substances in India as per the Gazette Notification of GSR 191 (E).
However, there have been instances of the customs department asking for an export no objection certificate (NOC) from the Central Bureau of Narcotics (CBN).
In view of this, a clarification from CBN was requested that preparations of ergotamine, ergometrine and similarly for substances mentioned in Band C, unless specified, do not require a NOC for export or import for the same.
CBN issued a public notice with reference to several representations by the IDMA stating that CBN would issue letters of no objection to export of such substances which are not under the purview of the Narcotic Drugs and Psychotropic Substances Act (NDPS Act, 1985) to applicants within 7 days from the date of an application with complete details.
The NDPS Act, 1985, commonly referred to as the NDPS Act, is an Act of the Parliament of India that prohibits a person the production, manufacturing, cultivation, possession, sale, purchasing, transport, storage, and/or consumption of any narcotic drug or psychotropic substance.
As a part of the representation, a number of issues concerning import/export permits, issuance and renewal of narcotic licenses, destruction of narcotics substances, clarification of substances not listed in NDPS, Annual Legitimate Requirements (ALR) issue for controlled substances among others were taken up. Some of the issues have been resolved by the Narcotics Commissioner. He also proposed a monthly review to review the progress of pending issues with CBN.
NCB also asked IDMA on the exponential increase in the import of acetic anhydride after 2018. IDMA clarified with legitimate reasons for the same and stated that acetic anhydride is a key raw material used in the manufacture of many APIs and intermediates. Several IDMA members are users of this chemical and in addition is a key solvent used in testing and analysis of several APIs, intermediates, aromatic chemicals, dyes and specialty chemicals.
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