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Policy Matters

Dept of Ayush gives one year time to implement sub-rule (1B) & (1C) in Rule 157 of D&C Act

Mumbai(PB): In a huge relief to the ASU manufacturers, the Department of Ayush recently gave one year’grace period to the industry before implementing the sub-rule (1B) and sub-rule (1C) in Rule 157 of the Drugs and Cosmetics Act, which bans the manufacturers from using any prefix or suffix with the name of licensed Ayurveda, Siddha and Unani medicines. It is understood that the Department took this decision to give one year extension after hearing out the woes of the industry who were vehemently opposing this move right from the beginning, fearing loss of business and confidence in the market over the impending ban.

Earlier, the department had decided to implement this rule after the Drugs Technical Advisory Board.(DTAB) had amended the Drugs and Cosmetics (D&C) Act to insert the D&C (5th Amendment) Rules, 2013 under which the department has inserted sub-rule (1B) and sub-rule (1C) after the sub-rule (1A) in Rule 157 of the D&C Act. The department’s sudden action in this regard comes following a decision to this effect by the DTAB to discourage the Ayurveda, Siddha and Unani drug manufacturers from mimicking the names of these drugs. The industry is apprehensive that if implemented, the ban could lead to a chaotic situation affecting all the stakeholders.

The Ayurvedic Drug Manufacturers Association (ADMA) have expressed a huge respite from this announcement as it will give the industry more time to take requisite steps. According to Chandrakanth Bhanushali, general secretary, ADMA, “Though we want the inserted rule to be deleted from D&C Act completely, we are grateful that the Department of Ayush has acknowledged our issues and given us the grace period to adopt these changes which sure to have huge repercussions on our business, if implemented. The government has taken this decision to extend the implementation date, after detailed analysis of the pros and cons of this Rule. We are hopeful that we will be able to press upon on this matter further with the government.”

It is understood that Ayush department has suggested the industry to take up this matter with the DTAB as well, as only they can take final decision with respect to removing this newly inserted Rule from the Act.

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