Rules and Regulations
1. Drugs and Cosmetics Act 1940 and Rules 1945:
The year 1660’s was the period for introduction of western medicine in India. First medical officers arrive along with the British East India Company's first fleet as ship's surgeons. In 1664 The Madras General Hospital is the first hospital opened in India. During the regime of the British India, the country faced development in the medical system and its legislation.
In 1940 the Drugs and Cosmetics Act is passed and drugs are made under the control of the government for the first time to regulate the import, manufacture, distribution and sale of drugs in whole of India.
Ayurveda, Siddha And Unani Drug 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 formulae described in, the authoritative books of Ayurvedic, Siddha and Unani Tibb systems of medicine specified in the First Schedule.
In Ayurveda, Siddha and Unani (ASU) system of drugs there are two types of medicine namely Sastric Medicine and Patent or Proprietary Medicine.
In Sastric Medicine, medicines are manufactured exclusively in accordance with the formulae described in the authoritative books of Ayurvedic, Siddha and Unani System of Medicine, as specified in the First Schedule of the Drugs and Cosmetics Act 1940 whereas in Patent or Proprietary Medicine includes medicine of all formulations containing only such ingredients mentioned in the formulae described in the authoritative books of Ayurvedic, Siddha and Unani System of Medicine, as specified in the First Schedule of the said Act.
The Chapter IV-A of the Drugs and Cosmetics Act 1940 provides provisions relating to Ayurveda, Siddha and Unani drugs for its various regulatory and prosecution to be followed.
The Part XVI and Part XVI-Aof the Drugs and Cosmetics Rules 1945 deals with manufacture for sale of Ayurvedic, Siddha and Unani drugs and Approval of institutions for carrying out test on Ayurveda, Siddha and Unani drugs and Raw material used in the manufacture on behalf of licenses for manufacture for sale of Ayurvedic, Siddha and Unani drugs respectively.
The Part XVII of the Drugs and Cosmetics Rules 1945 deals with labeling, packing and limit of alcohol in Ayurveda, Siddha and Unani drugs.
The Part XVIII of the Drugs and Cosmetics Rules 1945 deals with Government Analysts and Drugs Inspectors
In 1940 the Drugs and Cosmetics Act is passed and drugs are made under the control of the government for the first time to regulate the import, manufacture, distribution and sale of drugs in whole of India.
Ayurveda, Siddha And Unani Drug 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 formulae described in, the authoritative books of Ayurvedic, Siddha and Unani Tibb systems of medicine specified in the First Schedule.
In Ayurveda, Siddha and Unani (ASU) system of drugs there are two types of medicine namely Sastric Medicine and Patent or Proprietary Medicine.
In Sastric Medicine, medicines are manufactured exclusively in accordance with the formulae described in the authoritative books of Ayurvedic, Siddha and Unani System of Medicine, as specified in the First Schedule of the Drugs and Cosmetics Act 1940 whereas in Patent or Proprietary Medicine includes medicine of all formulations containing only such ingredients mentioned in the formulae described in the authoritative books of Ayurvedic, Siddha and Unani System of Medicine, as specified in the First Schedule of the said Act.
The Chapter IV-A of the Drugs and Cosmetics Act 1940 provides provisions relating to Ayurveda, Siddha and Unani drugs for its various regulatory and prosecution to be followed.
The Part XVI and Part XVI-Aof the Drugs and Cosmetics Rules 1945 deals with manufacture for sale of Ayurvedic, Siddha and Unani drugs and Approval of institutions for carrying out test on Ayurveda, Siddha and Unani drugs and Raw material used in the manufacture on behalf of licenses for manufacture for sale of Ayurvedic, Siddha and Unani drugs respectively.
The Part XVII of the Drugs and Cosmetics Rules 1945 deals with labeling, packing and limit of alcohol in Ayurveda, Siddha and Unani drugs.
The Part XVIII of the Drugs and Cosmetics Rules 1945 deals with Government Analysts and Drugs Inspectors
2. Drugs and Magic Remedies Act:
The Scope and Object of the Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954 (Central Act 21 of 1954) and Rules 1955 is to prevent self medication or self treatment and for that purpose advertisements commending certain drugs and medicines have been prohibited.
The advertisements in the instant cases relate to commerce or trade and not to propagating of ideas; and advertising of prohibited drugs or commodities of which the sale is not in the interest of the general public, cannot be speech within the meaning of freedom of speech and would not fall within Art 19(1) (a) of Constitution of India.
Advertisement includes any notice, circular, label, wrapper or other document, and any announcement made orally or by any means of producing or transmitting light, sound or smoke.
The advertisements in the instant cases relate to commerce or trade and not to propagating of ideas; and advertising of prohibited drugs or commodities of which the sale is not in the interest of the general public, cannot be speech within the meaning of freedom of speech and would not fall within Art 19(1) (a) of Constitution of India.
Advertisement includes any notice, circular, label, wrapper or other document, and any announcement made orally or by any means of producing or transmitting light, sound or smoke.
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