Unwarranted Changes About Ayurveda Products

            One now finds a marked change in Govt.’s policy towards Ayurved. The change is for the better. Once even most of us used to jeer at Ayurved, yoga and meditation, calling it a fad. But when foreign people found them good for health reasons, our views changed. More and more people are now conscious about the fact that exercise, sport, meditation and balanced diet contribute a lot towards having a healthy life.

            Indian universities have now introduced ‘Ayurved’ as a subject of medicine. Govt. has recently announced plans to establish an institute for ‘Ayurved’ on the line of All India Institute of Medical Science. All this is all right. But what is disturbing is the proposed changes in the Drugs and Cosmetics Act. All bill for amending the act is already introduced in the parliament and even a parliamentary committee on health and family welfare is examining the amendments. What is in the amended bill? What are its implications, we shall try to dwell on it in ongoing paragraphs one by one. First thing First. Are the changes necessary? The new entrants in the scope of amended laws will find it beneficial or harmful? Will it solve the problem? Or create new issues?

        In 1994, Govt. formed a new department that of ‘AYUSH’ to administer, regulate and provide specialized attention to ASU sector, i.e. Ayurved, Siddha and Unani. The ASU sector was neglected so far by the Ministry of Health and Family Welfare. 

               The ‘AYUSH’ is headed by a secretary level officer and in the course of last 13-14 years of its existence, it has done a commendable job for ASU sector. It has taken steps to strengthen and upgrade quality control mechanism and have brought about changes in the rules whenever and wherever necessary. AYUSH in their internal working system have formed statutory committees like AYUSH Pharmacopoeia Committee, ASU Drug Consultative Committee, ASU Drug Technical Advisory Board and have ensured effective consultation process with the stakeholders and have put in proper inputs from the experts in the field. The statutory bodies also ensured uniformity in implementation of quality assurance mechanism. At a state level, ASU sector is administered by the Food and Drugs Administrator or the Directorate of Indian System of Medicine – Homeopathy. The State Licensing Authority is responsible for issuing individual drug licenses and manufacturing premises. ‘AYUSH’ has changed with the time. It has not remained static. Only recently, they have taken steps and initiatives to streamline the process of grant of product permission for patent and proprietary medicines.

                One may now ask, why the changes when everything is in place! Why a new Central Drugs Authority? Has AYUSH failed? Certainly not. Of course, one thing must be conceded. When you talk about ayurvedic medicines, as an alternative. 

                system of medicine and it has global implications, then everything must be full proof. Internationally accepted standards need to be introduced and at all levels the ‘product’ must meet the set standards of quality, safety and efficacy. To be frank in the present system things do not look that rosy. The small players in the business of production do not care about standards, quality and specific procedures. The problem lies here. These people are responsible for bringing the ‘Ayurved’ into disrepute. That is why the authorities want to apply the breaks. But this they will solve some problems but at the same time will create many. 

            

            The licensing authority will be vested with Central Drugs Authority. Presently, it is done at the state level. Many of the ASU manufacturing units and companies are in small towns and rural areas. For them, renewing their licenses, filing of appeals etc. will be a cumbersome job. The introduction of clinical trials for any products, as a matter of fact betrays the provisions of Drugs and Cosmetics Act, 1940 and Rules 1945. There is an inbuilt legislative mechanism in the definition of ayurvedic drugs as per act to ensure the quality, safety and efficacy of the product. By virtue of the definition it’s mandatory for the manufacturers to follow the method and use the ingredients listed in the text books.

        Therefore, while accepting the anxiety of the authorities about setting good manufacturing practices, standardization, quality control, clinical trials, a careful reconsideration of the amendments need to be done, so that whatever good work that is already done will not be undone.