Ayush dept issues draft notification on prefix-suffix amidst industry opposition

In spite of strong opposition from the industry, the Department of Ayurveda, Yoga and Naturopathy, Unani, Siddha and Homoeopathy (Ayush) recently issued a draft notification banning prefix and suffix for 3(a) drugs as well as preventing resemblance and mimicking names for 3(h) formulations. It is understood that the government for some time had been mulling over the implementation of the newly inserted sub-rule (1B) and sub-rule (1C) after the sub-rule (1A) in rule 157 of the Drugs and Cosmetics Act. Through the notified draft sub rule 1B, the government plans to curb the manufacturers from using any prefix or suffix with the name of any Ayurveda, Siddha or Unani tibb drug falling under clause (a) of Section 3 of the Act, except as described in the authoritative books specified in the First Schedule to the Act, amid stiff resistance. Similarly the draft notified that under (1C) the names of any Ayurveda, Siddha or Unani tibb drug falling under clause (a) of section 3 of the Act shall not be used for naming any patent or proprietary medicine falling under these systems of medicine referred to in sub-clause (i) of clause (h) of the said section. As per the Drugs & Cosmetics Act (D&C) 1940, the drugs Sin traditional medicine covering Ayurveda, Siddha and Unani systems are licenced either under 3(a) category when the formulations are made as per the text, or under 3(h) category, when the formulations are essentially made using the ingredients of formulae from the schedule texts. The draft also states that notwithstanding the period for renewal of licence provided in rules 156 and 156A, the licensee of the Ayurveda, Siddha or Unani tibb drug, which is not in conformity with sub-rules (1B) and (1C), shall seek renewal of the license with appropriate name of the drug within a period of one year from the date of commencement of the Drugs and Cosmetics (Second Amendment) Rules, 2014. This comes with a condition that  this rule shall not be applicable to any batch of Ayurveda, Siddha or Unani tibb drugs manufactured prior to the date of commencement of the Drugs and Cosmetics (Second Amendment) Rules, 2014. The government has already asked the stakeholders to immediately send in their objections or suggestions on the same for further proceedings. Interestingly, according to a highly placed source from the industry, this move from the government comes in the wake of vehement opposition from the industry on this matter. In fact the industry, fearing huge setback to its growth, had been putting a tough fight with the government by not only resisting the ban of prefix and suffix for 3(a) drugs as well as preventing resemblance and mimicking names for 3(h) formulations, but demanding omission and nullification of the newly inserted sub rule from the Drugs and Cosmetics Act (D&C Act) altogether.

Source:Pharmabiz