The Union health ministry is planning to devise an action plan for surveillance of misleading advertisements of Ayush drugs. This according to the plan can be implemented with the setting up of a dedicated centre for monitoring safety of Ayush products in the country.
Meanwhile, Indian Pharmacopoeia Commission (IPC), Ghaziabad which is the National Coordination Centre (NCC) for Pharmacovigilance Programme of India (PvPI) has been training Ayush coordinators of pharmacovigilance centres of ayurveda, siddha, unani and homoeopathy in collaboration with All India Institute of Ayurveda (AIIA), New Delhi covering subjects like concept of Pharmacovigilance in Ayurveda, Siddha, Unani and Homoeopathy (ASU and H) drugs, methods used in pharmacovigilance and building-up of an effective pharmacovigilance system for Ayush products.
This comes at a time when Union Ayush Ministry has come up with stringent regulatory guidelines to prevent misleading and inappropriate advertisements of Ayurveda, Siddha and Unani (ASU) medications in the country. On December 21, 2018, the Central Government also introduced the eleventh amendment of Drug and Cosmetic (D&C) Rule, 2018, which addresses 'Prohibition of advertisements of Ayurveda, Siddha or Unani drugs' in public interest.
As of today, D&C Act, 1940, regulates the manufacturing, sale and distribution of ASU medicines under various provisions of D&C Rule, 1945, whereas, the Act which regulates the advertisement of prescription only drugs such as Schedule H, H1 and X to the general public, has not specifically addressed the advertisement of ASU drugs.
The Drugs and Magic Remedies (Objectionable Advertisements) (DMR) Act, 1954, which regulates the advertisement of 'drug', also covers all medicines, substances and articles other than food products.
The DMR Act empowers state government to authorise state food and drug administration officials to search, seize, examine any record, register, document or any other material object related to any objectionable advertisement, analyse and monitor the veracity of misleading advertisements under the provisions of the DMR Act.
Maharashtra government is currently reviewing the Maharashtra Food and Drug Administration (FDA) proposal for provisioning of ayurvedic drugs sale license in the D&C Act to effectively control spurious ayurvedic drugs sale.
Maharashtra FDA has been urging the state government since the past two years to include the provision of licence for the sale of ayurvedic drugs in the D&C Maharashtra Amendment Act to regulate spurious ayurvedic drugs sale.
Currently, state drug controllers have no control on ayurvedic drugs beyond registering manufacturers. Under the existing norms, state FDA has the power to seize spurious ayurvedic products but has no authority for prosecuting offenders found selling them.