The Ayurvedic Drug Manufacturers Association (ADMA) is soon planning to have a high level meeting with the DTAB,to deliberate and discuss the growing concerns within the industry over the impending ban on the use of prefix & suffix with name of licensed Ayurveda, Siddha & Unani drugs.
While vehemently opposing the October 25th notification of Ayush, banning prefix and suffix for 3(a) drugs as well as preventing resemblance and mimicking names for 3(h) formulations, the association hopes to urge the drug technical advisory board to omit and nullify the newly inserted sub rule from the Drugs and Cosmetics Act (D&C Act) altogether. ADMA informs that this step is very essential to ensure that the industry does not suffer due to its implementation as it can lead to a major set-back to the efforts of both the government as well as industry in the promotion of this niche sector in the country.
With this in mind the association plans to impress upon the DTAB the issues and complications arising out of 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. It is understood that the 5th amendment in its present form will adversely affect thousands of formulations directly or indirectly under both 3(a) as well as 3(h) category. As per the Drugs & Cosmetics Act (D&C) 1940, the drugs in traditional medicine covering Ayurveda, Siddha and Unani systems are licensed 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.
Chandrakanth Bhanushali, general secretary, ADMA, points out that companies have put in a lot of efforts through heavy investment in branding to build up these products. Therefore imposing a ban on the use of prefix and suffix is sure to have a huge impact on the stability of the brand itself. "Moreover, it is important to understand that prefix or suffix is added to the brand only after there has been a considerable and reasonable up gradation in the present product following a lot of research and development (R&D) activities to address the growing needs of the patients. Thus restraining the herbal industry by implementing the ban will lead to confusion among the consumers as they will not be able to differentiate between the products as per their needs," added Bhanushali.
The industry fears that the threat of the impending ban looming in the sidelines is sure to create confusion among the stakeholders while affecting its reputation and business in the long run. Thus it is understood that they are going to press for the omission of the newly inserted rule from the Act itself. Interestingly, acknowledging the problems faced by the industry, the Department of Ayush recently agreed upon to give one year time to implement sub-rule (1B) & (1C) in Rule 157 of D&C Act.