Gross negligence of states in monitoring fake and substandard medicines


The ambitious digital initiative launched by the Central Government to strengthen the monitoring of fake, substandard and non-standard medicines in the pharmaceutical market, which is directly related to the health of crores of citizens of the country, is not getting the expected momentum due to the apathy and negligence of the states. According to the official information revealed on Friday, November 13, 2026, out of the total 16 states and union territories that have applied for registration on the state-of-the-art 'Sugam Labs Portal' of the Central Drugs Standard Control Organization (CDSCO), only 5 states have completed their entire process so far. Health experts believe that timely implementation of digital surveillance system is extremely important to provide safe and effective medicines to the general public. But due to the administrative laxity being shown at the state level, there is unnecessary delay in fully implementing this important scheme of the Central Government. Details were sought in September, 11 states and union territories have not yet sent the information of drug testing laboratories. According to the information received from official sources, the Central Drugs Standard Control Organization (CDSCO) had in the month of September itself sought detailed details of the concerned nodal officers and state drug testing laboratories (Drug Testing Labs) from the administrations of all the states and union territories of the country to ensure registration on the 'Sugam Labs Portal'. However, the worrying situation is that out of 16 states and union territories that have applied to join the portal, 11 states have not yet provided this very important information to the central regulator. In view of this serious laxity of the states, the Central Drug Regulator has taken a tough stand and has written a formal letter to the drug controllers of all the states and issued strict instructions to immediately speed up the process of registration and data uploading. In the country, up to 3.5 percent of drug samples are found to be substandard, but there is no effective legal mechanism to withdraw substandard drugs from the market. Another serious and worrying aspect of this whole matter is that on an average, 3.2 to 3.5 percent of the drug samples tested regularly across the country are found to fail on quality standards i.e. substandard or fake. According to health and law experts, the problem is not only limited to identifying defective drugs in laboratories, but there is also no effective and strict legal mechanism in the country to immediately withdraw (recall) those batches of dangerous drugs from the market and medical stores after failing the test. In the present system, the rules applicable for withdrawal of defective medicines from the market are merely administrative guidelines and not any strict legally binding law. It is noteworthy that the Central Drug Regulator had made important amendments in these drug recall guidelines in July 2024, under which the direct responsibility of withdrawing the defective drugs from the market was put on the concerned drug manufacturing company and the marketing company, but despite this, no clear and punitive legal provision for mandatory drug recall has yet come into existence. What is the Central Government's 'Sugam Labs Portal' and how will the general public benefit from its full implementation? The main objective of 'Sugam Labs Portal' developed by 'Centre for Development of Advanced Computing' i.e. C-DAC, a prestigious institute of the Central Government, is to bring drug regulators, drug inspectors and government and recognized drug testing laboratories of the Center and States across the country on a single common and transparent digital platform. With the complete launch of this digital system, many major and revolutionary changes will be seen in the drug monitoring system of the country. Through this portal, the entire process from collecting samples of medicines from the market to their scientific testing in the laboratory and final approval of the test results will be recorded digitally in real-time. This will make it very easy to take prompt legal action against counterfeit medicines that do not meet the standards. Additionally, information exchange and mutual coordination between agencies of the Central and State Governments will increase and the process of preparing monthly monitoring reports will be fully automated and expedited. To fulfill this objective, CDSCO has asked the drug controllers of all the states to nominate nodal officers of their respective states as soon as possible, so that this life-saving system can be implemented 100 percent in the entire country.

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