The Maharashtra Food and Drug Administration (FDA) has submitted reports of action taken for non-compliance to Drugs and Magic Remedies (Objectionable Advertisement) Act (DMR Act) 1954 following its recent proposal to the state government to mandate issuance of sale license for ayurvedic drugs to effectively control its spurious sale.

In the ongoing crackdown for non-compliance to DMR norms, the state regulator found that ayurvedic drugs were mixed with allopathic medicines in contravention to the provisions of the DMR Act, 1954.

DMR Act seeks to curtail undesirable advertisements pertaining to drugs and magic remedies because advertising is considered to encourage self medication of harmful drugs. The Act lists the diseases and disorders in respect of which advertising is banned under Section 3 of the DMR Act.

Maharashtra has about 75,000 chemists licensed with FDA to sell allopathic drugs. Currently, the state has 600 Ayurveda licensed manufacturers, with 50 medium or large scale manufacturers and the remaining small-scale manufacturing units.

Based on the cases detected recently, the state regulator also launched around 78 prosecutions for violation of DMR Act 1954 under the provisions of Section 3(d) and Section 4.

Says Maharashtra FDA Joint Commissioner Amrut Nikhade, “Maharashtra FDA is close to bringing ayurveda medicine sale under its ambit as its proposal is in the process of getting reviewed by the law department of the state government. Norms will soon be amended to make the sale license compulsory for ayurvedic medicines in the interest of patient safety.”

Currently FDA has no control on ayurvedic drugs beyond registering manufacturers. As per the current provisions, each manufacturer must have a space of 1,200 square feet for production of drugs, approved machinery, an ayurvedic doctor and technician to monitor the procedure.

The proposal will also require amendment in the Drugs and Cosmetics Act to register retailers. A similar proposal was sent by the Maharashtra FDA in 2017 to register cosmetic retailers. The idea behind both proposals is to allow FDA to regulate supply chain and sale of these drugs. Under the existing Act, FDA has the power to seize spurious cosmetic or ayurveda products but holds less powers for prosecuting retailers found selling them.

Maharashtra FDA has also recently set up a special task force to address the issue of growing number of misleading advertisements broadcasted on electronic and print media with false health claims.

Maharashtra FDA Minister Girish Bapat is the head of the task force and seven joint commissioners from seven zones in Maharashtra are the members of the task force. The committee which will prepare the report will feature action plan and strategy to tackle the growing trend of misleading ads.

The main objective of DMR Act is to control the advertisement of drugs in certain cases and to prohibit the advertisement connected with remedies alleged to posses magic qualities and to provide for matters connected therewith.