Within the Central Government, specific ministries oversee particular products and their safety evaluation Regulatory agencies within each ministry determine the safety requirements and testing protocols for products in their jurisdiction. The table below summarizes the divisions most relevant to toxicity testing.
Product | Regulating Act | Regulatory Authority | Regulatory Ministry |
Drugs & Pharmaceuticals | Drugs & Cosmetics Act, 1940, Schedule Y & Rules, 1945 | ||
Cosmetics | Drugs & Cosmetics Act, 1940, Schedule S & Rules, 1945 | ||
Vaccines | Drugs & Cosmetics Act, 1940 & Rules, 1945 | Central Drugs Standard Control Organization Dept. of Biotechnology Genetic Engineering Appraisal Committee | Ministry of Health & Family Welfare |
Food & Food Products | |||
Genetically Modified Crops | Revised Guidelines for Research in Transgenic Plants 1998, Guidelines for the Safety Assessment of Foods Derived from Genetically Engineered Plants, Protocols for Food and Feed Safety Assessment of GE crops | Dept. of Biotechnology through
| Ministry of Science and Technology
|
Pesticide & Agricultural Chemicals | |||
Medical Devices | |||
Household chemicals, detergents, other surface-active agents | Chemical Council Division Committee | Bureau of Indian Standards |
Other relevant Indian agencies:
Central Insecticides Board (CIB)
Advises the government on regulations pertaining to the manufacture and use of insecticides, and helps the Ministry of Agriculture implement the Insecticides Act.
Council for Scientific and Industrial Research
Funded by the Ministry of Science and Technology, but operates as an autonomous organization to promote indigenous scientific research, technology, and entrepreneurship. Among other things, this organization funds research into non-animal testing technologies and models.
Indian Council of Medical Research (ICMR)
The “apex body in India for the formulation, coordination and promotion of biomedical research,” funded through the Ministry of Health and Family Welfare.
Department of Science and Technology
Promotes basic scientific research and technological developments, establishes guidelines and policies, works to popularize science education.
Department of Chemicals and Fertilizers
“The Department is entrusted with the responsibility of policy, planning, development and regulation of Chemicals and Petrochemicals Industries,” including the manufacture of insecticides, organic and inorganic chemicals, petrochemicals, dyes, synthetics, etc.
Bureau of Indian Standards
Formulates quality standards, establishes testing protocols and provides testing services, and provides training and consultations.