Government Set Up Validations and Quality Control Regulations of Herbal Medicines

WriteUps By Ayush

Central Government has published Ayurvedic pharmacopoeia incorporating quality standards of 645 single Ayurvedic drugs, 202 compound formulations; Unani Pharmacopoeia incorporating 150 compound formulations and quality standards of 298 single drugs and Siddha pharmacopoeia contains quality standards of 139 single drugs.

In respective Formularies, Standardised 985 Ayurvedic Formulations, 399 Siddha Formulations and 1229 Unani Formulations have been published. Development of standards of ASU medicines is an ongoing process that is managed by Pharmacopoieal Commission of Indian Medicine & Homeopathy and Pharmacopoeia Committees. Central and State Drug Laboratories for testing of ASU medicines are in place and for now 55 laboratories have been approved under the provisions of Drugs & Cosmetics Rules, 1945. It is imperative for the manufacturers to comply with the set  requirements for licensing of manufacturing units & medicines that also includes adherence to Good Manufacturing Practices (GMP) and quality standards of drugs given in the respective pharmacopoeia.

Proof of safety and effectiveness needed for issuing manufacturing license for different categories of ASU (Ayurvedic, Siddha and Unani) drugs is mentioned in Rule 158B of the Drugs & Cosmetics Rules, 1945. Accordingly, the Licensing Authorities/Drugs Controllers appointed by the State Governments that are empowered to grant as well as renew license for manufacturing of ASU medicines and to take required action against the defaulters working in contravention of the legal provisions.

As such, Herbal medicines are not defined in the Drugs & Cosmetics Act, 1940 and Rules. However, Ayurvedic, Siddha  and Unani (ASU) medicines formulated from herbal/plant materials and associated ingredients are regulated in the country via exclusive quality control provisions  mentioned in the Drugs & Cosmetics Act 1940 and Rules.  Fake medicines instances have also been reported that are defined in chapter IV A of the Drugs & Cosmetics Act, 1940  as adulterated, spurious and misbranded types along with the penal provisions for the defaulters. Substandard medicines complaints are forwarded to the respective State Regulatory Authorities for acting according to the legal provisions.

Reports of testing of ASU medicines received in this regard from some of the central and states laboratories during 2017-18 are as followed-




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 57015Prosecution  action   and  Departmental  action  are  being  taken against the defaulters
Chhattisgarh 5003Action was taken as per recommendation of Screening Committee formed as per Govt. of India.
Chandigarh 432NIL -
Delhi 23461908 cases are under process in Court.
Gujarat 7600--
Himachal Pradesh48744Action has been taken as per Drugs & Cosmetics Act, 1940 and Rules 1945.
Odisha53NIL --

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 125539Show cause notices issues.
Tripura 146NIL  
Uttarakhand 13834Show cause notices issues.
Puducherry 16NIL  
Central Pharmacopoeia Laboratory of Indian Medicine (PLIM)0701Test Reports submitted to Hon’ble Court.
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