Government set up quality control regulations and validations of herbal medicines

Central Government has published Ayurvedic pharmacopoeia containing quality standards of 645 single Ayurvedic drugs and 202 compound formulations; Unani Pharmacopoeia containing quality standards of 298 single drugs and 150 compound formulations and Siddha pharmacopoeia containing quality standards of 139 single drugs. Standardised 985 Ayurvedic Formulations, 1229 Unani Formulations and 399 Siddha Formulations are published in respective Formularies. Development of standards of ASU medicines is a ongoing process taken up by Pharmacopoieal Commission of Indian Medicine & Homeopathy and Pharmacopoeia Committees. Central and State Drug Laboratories for testing of ASU medicines are in place and as of now 55 laboratories are approved under the provisions of Drugs & Cosmetics Rules, 1945. It is mandatory for the manufacturers to adhere to the prescribed requirements for licensing of manufacturing units & medicines including compliance to Good Manufacturing Practices (GMP) and quality standards of drugs given in the respective pharmacopoeia. Proof of safety & effectiveness required for issuing manufacturing license for various categories of ASU medicines is prescribed in Rule 158B of the Drugs & Cosmetics Rules, 1945. Accordingly, the Licensing Authorities/Drugs Controllers appointed by the State Governments are empowered to grant or renew license for manufacturing of ASU medicines and to take necessary action against the defaulters acting in contravention of the legal provisions.

Herbal medicines as such are not defined in the Drugs & Cosmetics Act, 1940 and Rules there under. However, Ayurvedic, Siddha and Unani (ASU) medicines made from herbal/plant materials and other ingredients are regulated in the country through exclusive quality control provisions given in the Drugs & Cosmetics Act 1940 and Rules there under. Instances of fake such medicines have been reported, which are defined in chapter IV A of the Drugs & Cosmetics Act, 1940 as spurious, misbranded and adulterated types along with the penal provisions for the defaulters. Complaints of substandard medicines are forwarded to the respective State Regulatory Authorities for taking action in accordance with the legal provisions.

 

Reports of testing of ASU drugs received in this regard from some of the states and central laboratory during 2017-18 are as under-

State

No. of drug samples taken for testing

No. of samples not qualified

Action taken in accordance with the provisions of Drugs & Cosmetics Act and Rules.

Kerala 570 15

Prosecution action and Departmental action are being taken against the defaulters

Chhattisgarh 50 03

Action was taken as per recommendation of Screening Committee formed as per Govt. of India.

Chandigarh 432 Nil -Delhi 2346 19

08 cases are under process in Court.

Gujarat 76 00 ----Himachal Pradesh 487 44

Action has been taken as per Drugs & Cosmetics Act, 1940 and Rules 1945.

Odisha 53 Nil ---Karnataka 1056 29 Failed batches of medicine are withdrawn from the Market. Show cause notices issued and manufacturers instructed not to issue the failed batch of medicines. Sale of failed batches of medicines banned.Tamil nadu 1255 39 Show cause notices issued. Telangana 315 Nil Tripura 146 Nil Uttarakhand 138 34 Show cause notices issued. Pudducherry 16 Nil Central Pharmacopoeia Laboratory of Indian Medicine (PLIM) 07 01 Test Reports submitted to Hon'ble Court.

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