Union Govt. has issued a draft copy of the Drugs and Cosmetics (Fifth Amendment) Rules 2010 for the Ayush industry seeking to introduce licensing for production of herbal formulations. The new rules would be issued under section 33 N of the Drugs and Cosmetics Act 1940.
The fresh rules are for Ayurveda, Unani and Siddha drug manufacturers under section 3 (A), ‘Balya, Poshak, Muqawi and Unavuporutkal’ which are positive health promoter formulations having ingredients mentioned in the books of the First Schedule of the D&C Act and recommended for promoting and preventive health. The formulations under Saundarya Prasadak and Azhagh-sadan having ingredients recommended for oral, skin, hair and body are also provided with a set of procedures for production.
In a communique from the Ministry of Health and Family Welfare, Department of Ayush, via GSR 377(E) No. K11020/02/2010 DCC Ayush, comments were sought from the industry on the draft before the end of June, 2010. The rules will be finalized then and will be approved for publication in the Gazette.
The new set of rules will be introduced after Rule 158(A) as 158(B) of the Drugs and Cosmetics Act 1940.
According to the draft, the drugs for Ayurveda, Unani and Siddha will not require data submission on safety study and evidence of effectiveness but the use of ingredients should be according to Indian system of medicine texts.
For the issue of licenses for patent and proprietary drugs, safety study report is not required but manufacturers will need to submit a pilot study according to the protocol of Ayurveda, Siddha and Unani drugs.
For the Medicines prepared using ingredients listed in Schedule E (1) of the Drugs and Cosmetics Act, 1940, companies will need to furnish the safety data and proof of effectiveness.
The fresh rules are for Ayurveda, Unani and Siddha drug manufacturers under section 3 (A), ‘Balya, Poshak, Muqawi and Unavuporutkal’ which are positive health promoter formulations having ingredients mentioned in the books of the First Schedule of the D&C Act and recommended for promoting and preventive health. The formulations under Saundarya Prasadak and Azhagh-sadan having ingredients recommended for oral, skin, hair and body are also provided with a set of procedures for production.
In a communique from the Ministry of Health and Family Welfare, Department of Ayush, via GSR 377(E) No. K11020/02/2010 DCC Ayush, comments were sought from the industry on the draft before the end of June, 2010. The rules will be finalized then and will be approved for publication in the Gazette.
The new set of rules will be introduced after Rule 158(A) as 158(B) of the Drugs and Cosmetics Act 1940.
According to the draft, the drugs for Ayurveda, Unani and Siddha will not require data submission on safety study and evidence of effectiveness but the use of ingredients should be according to Indian system of medicine texts.
For the issue of licenses for patent and proprietary drugs, safety study report is not required but manufacturers will need to submit a pilot study according to the protocol of Ayurveda, Siddha and Unani drugs.
For the Medicines prepared using ingredients listed in Schedule E (1) of the Drugs and Cosmetics Act, 1940, companies will need to furnish the safety data and proof of effectiveness.
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