Drug testing laboratories in India operate under the Drugs and Cosmetics Act, 1940, mainly through Sections 16 to 20 and related rules. These provisions form the backbone of India’s drug quality and safety enforcement system.
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What Are The Standards of Quality Of Drugs
Section 16 sets the official quality standards for drugs. These standards are found in the Indian Pharmacopoeia or notified by the government. Every drug must meet these standards before it can be sold or distributed.
There are various type of drugs like the misbranded, adulterated, or spurious. A misbranded drug has misleading labeling or appearance. An adulterated drug contains harmful or contaminated substances. A spurious drug is falsely represented as another product or made by a different manufacturer. These definitions help regulators identify unsafe products.
Prohibition of Non-Compliant Products
The manufacture, sale, and distribution of drugs or cosmetics are banned that fail to meet quality standards. It also prohibits misbranded, adulterated, and spurious products. This makes compliance with drug quality rules legally mandatory.
What Is The Procedure for Analysis For Drugs
Section 19 explains how drug samples are tested. It outlines the process for laboratory analysis, preparation of reports, and handling of disputes over test results. This section ensures transparency and fairness in the quality assessment process.
The Central Government has the authority to appoint or recognize laboratories for drug testing. It also allows the government to define their roles, procedures, and operational standards, ensuring only accredited labs perform official testing.
What Is The Network of Drug Testing Laboratories
India has a network of Central and Regional Drug Testing Laboratories under the Central Drugs Standard Control Organization (CDSCO). These include the Central Drug Testing Laboratory (CDTL) and several Regional Drug Testing Laboratories (RDTLs). They check the quality of imported and domestic drugs, cosmetics, and medical devices. They also act as appellate authorities in disputed quality cases and support both legal and surveillance activities.
Many states operate their own drug testing laboratories. For example, Kerala runs four NABL-accredited labs. In addition, AYUSH drugs are tested in dedicated laboratories specializing in Ayurveda, Siddha, Unani, and Homeopathy medicines.
Accreditation
Most laboratories follow ISO/IEC 17025:2017 standards for chemical and biological testing. The Indian Pharmacopoeia Commission regularly updates drug standards, and compliance is mandatory for both domestic and imported drugs. These labs conduct quality control testing, train regulatory staff, and work with both central and state drug controllers.
Rules under the Act prescribe how samples are submitted, tested, and reported, including specific forms and fees. Some labs also process samples for private entities, enforcement agencies, and courts.
Conclusion
Sections 16 to 20 of the Drugs and Cosmetics Act create a strong legal foundation for drug quality enforcement in India. Supported by a wide network of accredited laboratories, the government ensures that medicines meet strict quality standards, protecting public health and maintaining confidence in the healthcare system.
