The drugs control wing of Ayurveda, Siddha and Unani (ASU) drugs in Kerala has moved a proposal to the state government to frame a law, in consultation with the central Ayush ministry, to regulate the purchase, sale, distribution and marketing of all ASU drugs and to bring the retail pharmacies under the regulatory body.
Along with, a registration and licensing system for ASU pharmacies has to be made mandatory within a legal framework as currently sale of Ayurveda, Siddha and Unani drugs is unregulated in the market. The law should be made on the lines of the guidelines for control of allopathic pharmacies. Information received from the ASU DC office states that there are over 25,000 retail Ayurveda pharmacies in the state. Homoeopathy is regulated by the allopathic drugs control office which controls the ASU wing also.
To ensure quality of the medicines sold through pharmacies, the functioning of the retail shops should be carried out by qualified Ayurveda pharmacists. If a law is framed for this, it will provide employment to hundreds of people who have passed the one year certificate course, Diploma in Ayurveda Pharmacy, states the drugs control wing. But it is learnt that the central government is reluctant to enact a law for controlling Ayush retail pharmacies as, except in Kerala, sufficient number of qualified pharmacists in Ayush streams is not available anywhere in the country at present.
According to sources, the Ayurveda DCA has also made one recommendation to the state government that a national level price control mechanism is required for essential drugs enlisted by the Ayush ministry. The essential drug list (EDL) of the union Ayush ministry was published in 2015, but the government did not declare any ceiling prices for the essential drugs listed in the EDL.
In Kerala, for reimbursement of expenses of Ayurveda treatments, the insurance agencies consider the prices of medicines sold by Oushadhi, the government manufacturing company. There are variations in prices of each category of medicine manufactured by different private companies.
It is learnt that the government of Kerala has already written to the union ministry of Ayush to bring in legislation for sale and distribution of traditional medicines under a regulated system. All the stores selling traditional medicines need to be registered with the local drug drugs regulatory office. In addition to the retail selling stores, wholesale, import of drugs from other states, storage systems, expiry and documentations have to be regulated. Legislation in this regard will enable the regulators to check the quality of the drugs brought for sale in the market.
In a telephonic conversation with Pharmabiz, the new state licensing authority (SLA) and drugs controller in-charge for Ayurveda, Dr. John P Smart, said the drugs control wing is facing a difficult situation to control advertisements violating the Drugs and Magic Remedies (Objectionable Advertisements) Act. Although legal actions are taken against them, some leading manufacturers go on with advertising in the media. So the DC wing is strongly gearing up to initiate legal steps against advertisements making tall claims of good results. Cases will be taken as per provisions of the DMROA. He said, presently 140 cases of violation of DMROA are pending with various courts. Despite legal actions, some big companies continuously make advertisements in TVs and in newspapers.
“We are unable to control the violation of provisions of DMROA by big players. Dhatri, Pankaja Kasthuri, Kandamkulathy, etc are the permanent violators of DMROA. Small companies normally do not repeat advertisements if they are warned or actions are taken against them. Big players, after paying the fine, continue the violation till the case is settled in the court. This tendency of the big manufacturers needs to be stopped at any rate”, said the new in-charge DC.