Manufacturing License

Manufacturing License

For manufacturing of Ayurvedic, Allopathic and Cosmetics drugs/products a manufacturing Licence is required as per Drugs and Cosmetics Act, 1940. The State licensing authority is liable to issue and monitor the various license like Drugs Sales License, Drugs Manufacturing License for Ayurvedic, Allopathic and Cosmetics etc. The other functions carried out by these offices are to do the regular inspections of the sales premises, drugs manufacturing unit and to prevent malpractice by implementing Food & Drug Act. Among these activities one of the major part of office work is to issue a manufacturer licenses (Drug) under the said Acts & Rules.

The licenses of Blood Banks, Blood components & Blood Products large volume Parenterals, Sera and Vaccines are also issued by the State Licensing Authority, but  only after an approval by the Central License Approving Authority i.e. The Drugs Controller General India New Delhi. For such licences, joint inspection of the premises is carried out by the officer of the State Drug Control and Central Drugs Standard Control Organization.

Good manufacturing practices compliance is mandatory to get regulatory approval. A separate application is filled as per the Drug and Cosmetic Act for drugs, herbal and cosmetics products. The Applicant has to submit the application in the prescribed format to the state Licensing Authority. The concerned Senior Inspector is then directed to inspect the premises and submit the report. Upon receipt of the report and it’s scrutiny either the license is granted or the application is rejected as the case may be. The licensee may apply for endorsement of additional items in the licenses which are sanctioned after due scrutiny. For approval of the Testing Laboratories to permit them to carry out test / analysis on behalf of the manufacturers, a joint inspection is carried out by the State and the Central Govt. Drugs Inspectors.  Various forms are to be filled and submitted to receive a manufacturing licence.

Reference

  1. Guidelines For Grant of Licences Under Drugs & Cosmetics Act, 1940 and Rules thereunder, by the Drugs Control Department, Govt. of N.C.T. of Delhi. Available at- http://drugscontrol.delhigovt.nic.in/Forms/Guidelines_Book.pdf, Accessed on-20th March 2016.

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