On Tuesday, Minister of State for Health, Bharati Pravin Pawar, disclosed that out of 88,844 drug samples examined between April 2021 and March 2022, over 2,500 drugs were found to be “not of standard quality,” while 379 were identified as spurious. During the same period, a total of 592 prosecutions were initiated for manufacturing, sale, and distribution of spurious or adulterated drugs, based on information provided by drug controllers from different states and union territories.
To combat this issue and ensure quality standards, the government has taken various steps in the pharmaceutical sector over the last five years. The Drugs and Cosmetics Act, 1940, was amended under the Drugs and Cosmetics (Amendment) Act 2008, imposing stringent penalties for the manufacture of spurious and adulterated drugs, with certain offenses now being made cognizable and non-bailable. Moreover, special courts have been established in states and union territories to expedite the trial of offenses under the Drugs and Cosmetics Act.
Additionally, measures have been implemented to enhance drug efficacy and safety. Applicants seeking manufacturing licenses for oral dosage forms of certain drugs are required to submit the results of a bioequivalence study. Before granting a manufacturing license, the establishment must undergo a joint inspection by drugs inspectors from both the center and the state. Evidence of stability and safety of excipients must also be submitted to the State Licensing Authority before granting a manufacturing license.
The Central Drugs Standard Control Organization (CDSCO) plays a pivotal role in coordinating activities with State Drug Control Organizations to ensure uniformity in administering the Drugs and Cosmetics Act. The Act regulates the manufacturing, sale, and distribution of drugs in the country, and compliance with license conditions is mandatory for manufacturers. Cases concerning drug quality or safety are addressed with the State Licensing Authority, and actions are taken under the provisions of the Drugs and Cosmetics Act, including possible prosecution in appropriate courts of law.
Through these measures and regulations, the government aims to improve standardization and quality within the pharmaceutical sector and safeguard public health.
Central Drugs Standard Control Organization Drug Control Organizations drug quality Drugs pharmaceutical sector safeguard public health spurious drugs
Last modified: July 25, 2023
