A parliamentary panel has recommended that these be regulated and untested and unlicensed formulations crowding the market, pushed by misleading advertisements, must be checked
By Ajith Pillai
Surf TV channels and you will invariably be confronted with numerous ads promising miracle cures. From diabetes, blood pressure, arthritis, thyroid dysfunction, epilepsy and kidney stones to infertility and losing or gaining weight, there are persuasive “physicians” from various schools of traditional medicine offering treatments. All you have to do is dial the number flashing on the screen and the magic powder/pill is home-delivered. What’s more—the promise is explicitly driven home that the cure’s USP is that it is “safe and without any side effects because it is made from natural herbs and hence is chemical free”.
How safe or reliable are these promises? Are the formulations being marketed licensed or tested? Towards the end of the last parliament session which concluded in the second week of May, the Parliamentary Standing Committee (PSC) on Health and Family Welfare tabled its 95th report on Demands for Grants 2016-17 of the Ministry of AYUSH (Ayurveda, Yoga and Naturopathy, Unani, Siddha and Homeopathy). It attracted very little attention in the midst of charged political debates, but raised the following pertinent issues:
- The licensing of drugs which come under traditional medicine category is currently a slow and tardy process, resulting in many unlicensed and untested formulations being sold in the market. Also, drug samples collected by inspectors from the market are far lesser than desired.
- Under the Drugs and Cosmetics Act, an existing allopathic drug to be sold in a modified form with new claims has to undergo clinical tests before being granted a license. However, the Act does not lay down any specific norms for AYUSH drugs.
- The Drugs and Magic Remedies (Objectionable Advertisements) Act 1956 has to be amended and given more teeth so that those advertising miracle cures can be prosecuted, their clinics wound up and such treatments banned. Currently, the Act only bans advertising but the law is being violated with impunity as is evident from the number of ads in the media promising quick-fix cures and remedies.
The government is aware of the problem. In fact, Minister for AYUSH, Sripad Naik assured parliament after the PSC report was tabled that loopholes in the law would soon be plugged. “The government is in the process of bringing the amended Drugs and Magic Remedy Act. The Law department has already approved it. Medicines sold through such advertisements while misguiding the public should be stopped,” he said.
In December 2015, Naik had addressed the same concerns when he noted that his ministry was aware of unscrupulous manufacturers of so-called herbal products flooding the market and selling their untested formulations through advertisements that made tall promises. He informed the House that the Kerala government had filed 25 cases against various firms for releasing misleading advertisements to promote their products. The Gujarat government had issued notices to 117 manufacturers while state governments in Delhi and Uttarakhand had initiated similar action against 13 companies and four firms respectively. With the current government’s focus on yoga and traditional cures, such cases will only go up.
While stopping ads and prosecuting those who promise cures should be given priority, another area of concern, according to the PSC, is the certifying and licensing of drugs as well as testing the quality and efficacy of products already in the market. The number of samples collected by drug inspectors is clearly not keeping pace with new AYUSH drugs in the market. While 40,000 samples of allopathic medicines were collected for testing in 2015, the number for AYUSH drugs for three years (2013-2015) was only 11,889. This shows that the inspectors did not show as much keenness to test tradition Indian medicines as they did for allopathic drugs.
The AYUSH Ministry has a Drug Control Cell (DCC) to administer regulatory and quality control provisions for traditional and homoeopathic drugs. The cell functions keeping in mind the Drugs and Cosmetics Act. It coordinates with licensing authorities and drug controllers in states to achieve uniform administration of the Act and for providing regulatory guidance and clarifications.
The secretary of AYUSH Ministry, Ajit Sharan, informed the PSC on March 21 that the testing and keeping an eye on quality control had a “major lacuna” because the tests were conducted by agencies of various state governments. “Licensing of new products is with the state licensing authorities. They are very ill-equipped, both technically and infrastructurally, to handle this task. Many states do not have AYUSH Inspectorates. It is the allopathic side which does it (tests) and for them it is of very low priority. It is very easy to convince them about a new drug with new indications.”
A senior official in the AYUSH Ministry told India Legal that what a new AYUSH drug is must be defined. According to him, all that is required for giving a license to a new drug is some proof of its effectiveness and safety. “This is currently done through testimonies of doctors who practice traditional medicine or by showing positive media reports on a remedy. This is taken as proof of efficacy and safety of a formulation.”
Sharan submitted to the PSC that rules relating to new drugs are being framed by the ministry. Under the new regulation, to be implemented soon, unless detailed clinical trials of a new AYUSH drug are conducted to validate its efficacy and safety, the state licensing authority cannot give a license. The new rules, it is hoped, will do away with the arbitrary manner in which drugs are cleared.
Also on the anvil, the PSC has noted in its report, is a proposal to set up a central drug regulator for AYUSH medicines. The idea is to create a “vertical structure” in the Central Drugs Standards Control Organization (CDSCO) and having a separate Drug Controller General of AYUSH. This, it is hoped, will regulate the manufacture and sale of traditional formulations.
In fact, the PSC in its report has recommended that “a credible regulatory and certification system” must be put in place and that “manufacturers of all patent and proprietary (traditional) drugs which have been introduced in the market in the last ten years should be required to prove their efficacy and safety through clinical trials over a period of the next five years”.
On the issue of misleading advertisements, the ministry submitted to the PSC that this was due to the ineffectiveness of the Drugs and Magic Remedies (Objectionable Advertisements) Act, 1956. The Committee was informed that a new set of rules have been drafted for the effective regulation of content of such advertisements and the rules will be notified as soon as they are vetted by the Ministry of Law and Justice.
While the AYUSH sector needs to be reined in, ministry sources point out the regulators appointed must be given a free hand to crackdown on those who violate norms. As one AYUSH Ministry official put it: “People with high political connections and those associated with influential ashrams and spiritual organizations have jumped into the field, so it is important to ensure that no favoritism is shown in giving clearances.”
If the guidelines drawn up are not strictly and impartially followed, he fears that regulating this sector will not be as effective or credible enough.