In 2011, the Government of India banned the pediatric use of Nimesulide, a nonsteroidal anti-inflammatory drug, with pain and fever relieving properties. Various countries like Finland, Switzerland, Spain, etc, had banned the drug as early as 2001 due to its adverse effects on the liver. India, on the other hand, continued to allow its usage for adults despite its hepatotoxicity for many years before joining the league of countries that imposed a ban. Analgin, a painkiller and anti-pyretic drug, is another example of a drug banned in several markets, but used in India. The medicine is banned in countries including the US, Japan, Sweden, Canada, France and Australia. Developing countries like Nigeria and Nepal have also prohibited its usage. However, the medicine is easily available in India. The Indian government, in 2013, had decided to suspend the sale of Analgin after there were concerns raised from various quarters, especially the Parliamentary Standing Committee, highlighting its various side-effects. However, the ban was lifted a year later with an advisory for the companies to carry a warning on their package along with promotional literature specifying its usage, reported Business Standard. DCGI, CDSCO and Drug Approval The Central Drugs Standard Control Organisation (CDSCO) is a central drug authority under the Ministry of Health and Family Welfare that regulates the quality, safety, and efficacy of drugs. The CDSCO is responsible for clinical trials in the country, the approval of new drugs, as well as checking the quality of imported drugs. Section 26A of the Drugs and Cosmetics Act, 1940, empowers the organisation to ban a drug considered harmful or sub-therapeutic. The CDSCO is headed by the Drug Controller General of India (DCGI), who is the highest authority of the pharma regulatory framework in the country. According to Prashant Reddy, co- author of The Truth Pill; the pharma companies need to submit on the trials and efficacy of drugs in order to unban the drugs. “This, however, has a lot of discrepancies as there is a lack of transparency,” he said. Low Manufacturing Cost “Analgin is very cheap to manufacture and many Indian companies may, therefore, like to sell the product”, Amit Sengupta, a medical practitioner and also the co-convenor of Jan Swasthya Abhiyan, told Business Standard. There have been several instances where the ban on medicines was revoked with dosage warnings and no changes in composition. Analgin is one of them. Lack of Data on Adverse Drug Reactions According to the National Centre for Biotechnology Information (NCBI), adverse drug reaction (ADR) refers to any harmful effect due to the use of a medicinal product. ADR plays a very important role in determining whether a drug should be pulled off the shelves or not. A study published in Authorea in 2020 states that the rate of ADR reporting is less than 1% in India due lack of awareness among healthcare professionals and patients. An NCBI study in 2014 cited a “dearth of research” claiming the presence of ADR in India. “They don’t have a proper system to collect data,” Prashant Reddy stated, adding, “There is no transparency.” “The drug approval process in India is quite dodgy.” -Prashant Reddy, Co- author, The Truth Pill
27 Oct 2022
Uzma Afreen
