Time to bring laws to regulate supply and sale of ASU medicines

The issue took the spotlight when a parliamentary panel recently called for standard licensing process for ASU medicines to meet global scientific scrutiny. The Department-Related Parliamentary Standing Committee on Health and Family Welfare has recommended to the Union Ayush Ministry to establish a standard licensing process

The issue of bringing a law to regulate wholesale and retail business of ayurveda, siddha and unani (ASU) medicines in the country, on the lines of the one in vogue for allopathic medicines, has been pending for a long time now. Currently license is required only for manufacturing of drugs and this is where the problems arise.

Wholesale and retail distribution of ASU medicines are carried out without any sale licence or regulation by the authorities. In the absence of regulations, thousands of retail outlets of various ASU manufacturing companies or independent shops are selling products without the supervision of any competent person.

The Drugs and Cosmetics Act does not stipulate any mandatory licensing system for sale of ASU medicines. The manufacturers themselves handle the distribution and allot agencies as per their whims and fancies. In such a background, there should be a uniform system for distribution and sale of the traditional system of medicines. The central government should think of this burning issue and frame rules for effective control over marketing of ASU products. It can be done either through amendment to the Drugs and Cosmetics Act or by bringing a separate law to regulate wholesale and retail business of ASU medicines like in the case of allopathic medicines.

The issue took the spotlight when a parliamentary panel recently called for standard licensing process for ASU medicines to meet global scientific scrutiny. The Department-Related Parliamentary Standing Committee on Health and Family Welfare has recommended to the Union Ayush Ministry to establish a standard licensing process based on uniform parameters across all the States so that drug formulations do not vary from state to state and conform to global norms of safety and efficacy. The Committee, which expressed its disappointment that the Ayush Ministry has not given any information about reasons for poor export of ASU drugs, also expressed its concern about ASU drugs failing to meet global norms on safety and efficacy.

The panel, headed by Prof. Ram Gopal Yadav, recommended that the role of the Pharmacopoeia Commission of Indian Medicine for maintaining standards of ASU drugs needs to be strictly monitored for assured sale standardization of ASU medicines. It also recommended that States/UTs must be motivated and incentivized to ensure standardization of ayush education and quality healthcare delivery system in general and on quality control of ASU medicines in particular.

The parliamentary panel has rightly identified the issues involved in regulating ASU medicines. It is a fact that there is lack of uniformity in the approach of different States with respect to their sale and distribution as health is a state subject. It rightly urged the government to establish a standard licensing process as this would go a long way in establishing the Indian system of medicine as an alternative system. Merely writing to State Governments to check the practice of Ayush system by quacks, the Ministry of Ayush should not absolve itself of its responsibility to stop this menace as it not only brings disrepute to the Ayush system but also discourages people to have trust in this system, it said.

The Ministry has been asked to come up with a governing code under which stern legal action could be taken against quacks. The committee recommended that the Union Ministry of Health & Family Welfare must examine and consider the regulatory amendments under Drugs and Cosmetics Act as suggested by the Ministry of Ayush without delay to improve the quality, efficacy and safety of ASU drugs.

Due to lack of rules to regulate Ayurveda pharmacies, the drug authorities cannot inspect retail outlets and the regulators do not know what kind of medicines are sold by pharmacies and whether the medicines are efficacious and potent. If a legal provision to control the sale of ASU drugs is in place then certainly drug inspectors can conduct searches at retail and wholesale premises and take samples for testing. It will go a long way in ensuring the safety and efficacy of ASU medicines, which will be a healthy development for the people who take them.

(The author is a freelance journalist with varied experience in different fields)