Gujarat Ayurvedic Aushadh Manufacturers Association (GAAMA) has urged the department of Ayush to bring the Ayurveda based food supplement industry under the preview of the Schedule T of the Drugs and Cosmetics (D&C) Act, so as to ensure uniform implementation of the law across the sector. This appeal was made to ensure that all the Ayurveda based food supplement manufacturers using ayurvedic plants and raw materials in their products should also be made to follow the rules and regulations like the Ayurveda drug manufacturers to safeguard the interest of the ASU industry at large.
The association blamed that it was unfair on the part of the government to adopt double standard within the sector, which requires all ayurvedic drug manufacturers to strictly adhere to the said Act, whereas on the other side exempts ASU food supplement manufacturers from the scrutiny. GAAMA pointed out that lack of uniform regulation in the Ayurveda sector for the ASU drugs manufacturers and Ayurveda based food supplement manufacturers is creating a lot of confusion and distrust in the industry. hampering its growth.
Schedule T of the D&C Act deals with the provisions relating to the rules and regulations that ASU drug manufacturers have to strictly comply with for manufacturing and marketing their products in the country. Interestingly, Schedule T is applicable only to those companies manufacturing products as ASU drugs and not for those who are into manufacturing food supplements, thus exempting them from any regulatory requirements.
Prabodh Shah, president, GAAMA informed that due to lack of clarity in the law, some of the manufacturers who use plant ingredients in their products, also used to make ASU drugs, strategically sell their products as food supplements to escape the regulatory requirement even though their products more or less fall under the category of drugs.
“Since they are exempted from following any regulatory provisions they simply do not ensure that their products meet the highest quality standard as required thus putting the reputation of the whole industry at stake. Our point of contention is, why are they exempted from the law when they too are selling the same products, which are sold as drugs in the market, only because they sell them as food supplements. Government needs to take immediate action to bring in more clarity and transparency on this matter,” Shah argued.
GAAMA stressed that regulating the manufacturers who sell food supplements containing ayurvedic herbs will help in maintaining the standard of the industry. Thus they suggested that to safeguard the industry and its reputation, the government should enforce and bring them under the purview of the law, as this will ensure universal law for all the Ayurveda based products moving in the market.
Source:Pharmabiz
The association blamed that it was unfair on the part of the government to adopt double standard within the sector, which requires all ayurvedic drug manufacturers to strictly adhere to the said Act, whereas on the other side exempts ASU food supplement manufacturers from the scrutiny. GAAMA pointed out that lack of uniform regulation in the Ayurveda sector for the ASU drugs manufacturers and Ayurveda based food supplement manufacturers is creating a lot of confusion and distrust in the industry. hampering its growth.
Schedule T of the D&C Act deals with the provisions relating to the rules and regulations that ASU drug manufacturers have to strictly comply with for manufacturing and marketing their products in the country. Interestingly, Schedule T is applicable only to those companies manufacturing products as ASU drugs and not for those who are into manufacturing food supplements, thus exempting them from any regulatory requirements.
Prabodh Shah, president, GAAMA informed that due to lack of clarity in the law, some of the manufacturers who use plant ingredients in their products, also used to make ASU drugs, strategically sell their products as food supplements to escape the regulatory requirement even though their products more or less fall under the category of drugs.
“Since they are exempted from following any regulatory provisions they simply do not ensure that their products meet the highest quality standard as required thus putting the reputation of the whole industry at stake. Our point of contention is, why are they exempted from the law when they too are selling the same products, which are sold as drugs in the market, only because they sell them as food supplements. Government needs to take immediate action to bring in more clarity and transparency on this matter,” Shah argued.
GAAMA stressed that regulating the manufacturers who sell food supplements containing ayurvedic herbs will help in maintaining the standard of the industry. Thus they suggested that to safeguard the industry and its reputation, the government should enforce and bring them under the purview of the law, as this will ensure universal law for all the Ayurveda based products moving in the market.
Source:Pharmabiz
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