What are the various laws governing Drugs in India?
- Drugs and Cosmetics Act, 1940
and corresponding Rules, 1945
- Dangerous Drugs Act, 1930.
- The Pharmacy Act, 1948
- The Drugs and Magic Remedies
(Objectionable Advertisement) Act, 1954
- The Narcotics Drugs and
Psychotropic Substances Act, 1985
- The Medical and Toilet
Preparations (Excise Duties) Act, 1956
- The Drugs Price Control Order
(DPCO), 2013
What are the different bodies of government?
- The Drugs Technical Advisory
Board
- The Central Drugs Laboratory
- The Drugs Consultative
Committee
- Central Drugs Standard
Control Organisation
- Ministry of Health &
Family Welfare
- Ministry of Chemicals and
Fertilizers
i. Department
of Chemicals & Petro-Chemicals
ii. National
Pharmaceutical Pricing Authority- Drugs Price Control Order
DRUGS AND COSMETICS ACT, 1940
What are drugs and cosmetics?
- Drugs include all medicines
intended for internal or external use for diagnosis, treatment, mitigation or
prevention of a disease.
- Inclusive of Ayurvedic,
Siddha or Unani.
- Cosmetics means any article
intended to be rubbed, poured, sprinkled or sprayed on to the human body for
cleaning or beautifying.
What are the standards of quality?
- The drugs need to comply with
the standards set out in Second Schedule.
- Cosmetics need to comply with
the standards prescribed.
What are misbranded/adulterated/spurious drugs and cosmetics?
- If the the same is colored,
coated or powdered in a manner to conceal the damage or show a better value
than it has.
- If the same is not labelled
properly or makes any false claim via passing statement, design or device.
- If the same consists filthy,
putrid or decomposed substances or packed under unsanitary conditions and is
contaminated which can be dangerous to the human health.
- If the same contains any
toxic substances or any substances which aren’t disclosed to the users.
- If the same are imported under a name which belongs to another drug/cosmetic or under any other fictitious individual or company.
Selling or using of these drugs/cosmetics is prohibited.
What are the offences and punishments in case of importing such drugs?
- As per section 13(a) of the Act- Punishment for a term which may extend to three years and a fine upto Rs. 5000 for selling misbranded/adulterated/spurious drugs and cosmetics.
- As per section 13(b) of the Act- Punishment for a term which may extend to six months or with fine extending to Rs. 500, or with both for importing drugs prohibited under Section 10 of the act.
- As per section 13(c) of the
Act- Punishment for a term which may extend to three years or with fine
extending to Rs. 5000, or with both for contravening with any of the provisions
of the Act.
What are the offences and punishments in case of manufacturing and distributing such drugs?
- As per Section 27(a) a person shall be liable under section 320 of IPC is use of any adulterated or spurious drug is administered with intention to cause grievous hurt or death with a term which shall not be less than 10 years and extend upto life time and fine upto Rs. 10,00,000 or three times the value of the drugs. The fine obtained shall be paid to the person suffered as compensation.
- As per Section 27A (i) a person shall be liable for a term extending to three years and with fine shall not be less than Rs. 5,000 or three times the value of cosmetics confiscated when the sale or manufacturing is done in contravention to the act.
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