The drugs include Calcium and Vitamin D3, anti-worm medication, anti-bacterial medication, Paracetamol tablets among others.
New Delhi: The Central Drugs Standard Control Organisation (CDSCO) has identified as many as 211 drugs manufactured by different pharmaceutical companies as not of standard quality (NSQ) in the month of October this year.
The drugs identified by Central Drugs Laboratories as well as State Drugs Testing Laboratories include Calcium and Vitamin D3 Tablet, anti-worm medication, antibiotic used to treat serious bacterial infections, Paracetamol tablets among others.
The list of drugs detected by CDSCO as not of standard quality in possession of ETV Bharat said that central drugs laboratories have identified 63 drug samples to be not of standard quality and state drugs testing laboratories have identified 148 drugs samples as not of standard quality.
Several of the drugs which were identified as not of standard quality have been manufactured by different pharmaceutical companies from across the country including Mohali based Vzoic Healthcare Pvt. Ltd. (Punjab), Solan based Azot Life Sciences (Himachal Pradesh), Haridwar based Bengal Chemicals And Pharmaceuticals (Uttarakhand), Gujarat based Gidsha Pharmaceuticals, Madhya Pradesh based Cureza Healthcare Pvt. Ltd., West Bengal based Diamond Drugs Pvt. Ltd, Ghaziabad based Chemetac Pharmaceuticals (Uttar Pradesh) among others.
Further, in October, three drugs samples from Bihar, two drugs samples from Delhi are identified as spurious drugs, which were manufactured by unauthorized manufacturers using brand names owned by other companies. “The matter is under investigation and action will be taken as per Act & Rules,” the official added.
According to the official, manufacturers found with producing drugs not of standard quality are served with stop production orders, stop testing orders, license suspensions as well as cancellations, warning letters, and show cause notices based on the severity of non-compliance.
The action of identifying NSQ and spurious medicines is taken on a regular basis in collaboration with state regulators to ensure that these drugs are identified and removed from the market.
“The list of NSQ drugs is prepared through active involvement of different regulators at central and state level. It demonstrates the strength of a regulatory system towards improvement of quality of medicines used in public health,” the official said.
In the last three months 349 drugs manufactured by different pharmaceutical companies have been detected as not of standard quality. According to the CDSCO data, 143 drugs have been identified as not of standard quality in the month of July followed by 94 in August and 112 in September.
The Central Drugs Standard Control Organisation under the Directorate General of Health Services, Ministry of Health & Family Welfare is the National Regulatory Authority (NRA) of India.
The Drugs & Cosmetics Act,1940 and rules 1945 have entrusted various responsibilities to central & state regulators for regulation of drugs & cosmetics.
CDSCO is entrusted to bring out transparency, accountability and uniformity in its services in order to ensure safety, efficacy and quality of the medical product manufactured, imported and distributed in the country.
Under the Drugs and Cosmetics Act, CDSCO is responsible for approval of Drugs, Conduct of Clinical Trials, laying down the standards for Drugs, control over the quality of imported Drugs in the country and coordination of the activities of State Drug Control Organizations by providing expert advice with a view of bring about the uniformity in the enforcement of the Drugs and Cosmetics Act.
Last year, the CDSCO published regulatory guidelines for the sampling of drugs, cosmetics, and medical devices by drugs inspectors of central and state drug authorities in the country. The guidelines provide a structured approach to ensure the quality and efficacy of products available in the market through uniform drug sampling methodology for drug inspectors under state and central drug regulatory authorities in India.
It covers various aspects of sampling, including sampling plans, selection, locations, number and quantity of samples, timelines, and role of testing laboratories. It stresses the importance of a structured sampling plan, risk-based sample selection, and covering diverse locations, including rural areas
Talking to ETV Bharat, Dr Giridhar Gyani, director general of association of health care providers-India, said that the monthly initiative adopted by the drug regulator is very much necessary to check the adulterated and not of standard quality drugs.
“Identification of drug samples as NSQ is done based on failure of the drug sample in one or the other specified quality parameters. The failure is specific to the drug products of the batch tested by the Government laboratory and it does not warrant any concerns on the other drug products available in the market,” said Gyani.
The association of health care providers advocates with the government, regulatory bodies and other stakeholders to deliver appropriate healthcare services to the community at large.
