Drugs and Cosmetic Act, 1940 is an act to regulate the import, manufacture, distribution and sale of drugs and cosmetics. Ayurveda, Siddha or Unani drugs includes all medicines intended for internal or external use for or in the diagnosis, treatment, mitigation or prevention of disease or disorder in human beings or animals, and manufactured exclusively in accordance with the formulate described in, the authoritative books of Ayurveda, Siddha and Unani Tibb system of medicine, specified in the first Schedule.
Provisions of D&C Act 1940 applicable to ASU drugs
33C. Ayurveda, Siddha and Unani Drugs Technical Advisory Board, 33D. Ayurveda, Siddha and Unani Drugs Consultative Committee, 33E. Misbranded drugs, 33EE. Adulterated drugs, 33EEA. Spurious drugs, 33EEB. Regulation of manufacture for sale of ASU drugs, 33EEC. Prohibition of manufacture and sale of certain ASU drugs, 33EED. Power of Central government to prohibit manufacture, etc., of ASU drugs in the public interest, 33F. Government Analysts, 33G. Inspectors, 33H. Application of provisions of sections 22, 23, 24 and 25, 33-I. Penalty for manufacture, sale, etc., of ASU drugs in contravention of this Chapter, 33J. Penalty for subsequent offenses, 33K. Confiscation, 33L. Application of provisions to Government departments, 33M. Cognizance of offenses, 33N. Power of Central Government to make rules, and 33O. The power to amend the first Schedule.
Schedule E of D&C Rule 1945
Schedule E of Drugs & Cosmetics Rule 1945 contains a list of poisonous substances under the Ayurveda (including Siddha) and Unani Systems of medicine. Such Ayurveda, Unani & Siddha drugs containing any of the potentially hazardous ingredients of plant, animal and mineral origin as specified in the Schedule E (1), Rule 161(2) of the Drugs and Cosmetic Rules, 1945, are required to be taken under medical supervision. As per legal provisions, caution is to be printed on the label of the container of such medicines.
Revision of Schedule E (I)
In the list of Schedule E of Drugs & Cosmetics Rule 1945, only some parts of the plants are found poisonous whereas the rest of the plant is not poisonous and some of the names were found incorrect. The matter was examined in detail and finally as per recommendations of ASU Drug Technical Advisory Board (ASUDTAB), Schedule E (I) has been revised and necessary amendments in the list of plants and names etc. for Ayurveda, Unani & Siddha poisonous drugs have been carried out. Draft Notification in this regard was issued on 13th April, 2010.
Public Notice from Ayush
Department of Ayush (formerly Dept of ISM&H) has issued a public notice on 15th January, 2016. The notice clearly has advised the public to purchase and consume Ayurveda, Unani & Siddha drugs only on the prescription of the institutionally qualified and registered practitioner of the respective system. Further the notice also warns to avoid purchasing the Ayurveda, Unani & Siddha drugs online and using them without medical consultation.
Manufactures of Ayurveda, Unani & Siddha drugs must ensure to imprint ‘Caution: to be taken under medical supervision’ both in English and Hindi on the labels of all such Ayurveda, Unani & Siddha drugs which contain potentially hazardous ingredients of plant, animal or mineral origin as specified in the 2nd Schedule E(1) of the of the Drugs and Cosmetic Rules, 1945. Cases of the contravention of these provisions, as and when found, may be immediately brought to the notice of the concerned State Licensing Authority for appropriate action.
List of poisonous substances under Ayurveda
A. Drugs of vegetable origin
Abrus precatorius Linn. (Seed), Aconitum chasmanthum Stapf.ex Holmes, Aconitum ferox Wall, ex Ser., Baliospermum montanum Mull. Arg.,Calotropis procera (Ait.) R. Br, Cannabis sativa Linn. (Except seeds), Croton tiglium Linn., Datura metal Linn., Gloriosa superba Linn., Hyoscyamus niger Linn., Nerium indicum Mill, Papaver somniferum Linn. (except seeds), Semecarpus anacardium Linn. f., and Stychnos nux vomica Linn.
B. Drugs of animal origin
Snake poison
C. Drugs of mineral origin
Arsenic, Arsenic trisulphide, Arsenic disulphide, Mercury, Hydrargyri subchloridum, Copper sulphate and Cinnabar.
If more than the Schedule E is required?
The steps taken by the Department of Ayush in the revision of Schedule E (I) in 2010 and issuing a public notice in 2015 are welcome from the quality assurance point of view. Office order by the Department of Ayush in 2005 regarding imprint on heavy metals within permissible limits provided much needed support to the Ayurvedic drug industry particularly at the international level.
The steps taken by the Department of Ayush in the revision of Schedule E (I) in 2010 and issuing a public notice in 2015 are welcome for the consumer buying products manufactured by pharmaceutical companies. Some vaidyas and Hakims use poisonous substances in preparation of medicines and prescribe in clinical practice. The Schedule E need to be amended in this respect also as several case reports about Ayush drug poisoning at clinical level have been published.
Impact on ayurvedic drug industry
Herbal extracts and proprietary ayurvedic medicines are in high demand. Traditional tyurvedic formulations are in also in demand and prescribed by ayurvedic practitioners. They are being sold through the internet also as e-commerce business. After publication of article regarding heavy metals in ayurvedic formulations in Journal of American Medical Assocation (JAMA), the sales of ayurvedic formulations containing heavy metals was hit. The US FDA also issued a public notice regarding permissible limits of heavy metals in ayurvedic formulations.
The public notice issued by Department of Ayush is also on the same lines and consumers should know about poisonous constituents which are used in ayurvedic formulations. As an instance, Aconitum ferox Wall ex Ser. (Ranunculaceae) is part of herbo-mineral preparations like Tribhuvanakirti Rasa, Higuleshwara Rasa, Anandabharirava Rasa, Sutashekhar Rasa, Ramban Rasa, Mrityunjaya Rasa, Arshakuthara Rasa, Agnikumar Rasa, Prataplankeshwara Rasa, and Ashwakanchuki Rasa. Tribhuvanakirti Rasa is commonly used in the treatment of common cold and is highly efficacious also. As per ayurvedic methodology, Aconitum feroxis purified by the methods mentioned in ancient texts and after purification only, it is used in formulations. ayurvedic physicians claim that after purification, Aconitum ferox becomes non-poisonous. We need to verify ancient claims by modern research methods so that claims are not missed out as far as public benefit is concerned.
(Author is a herbal consultant based in Mohali)