Indian Pharmaceutical Companies Under Scrutiny; Less Than a Quarter of Small Factories Meet International Standards

Indian pharmaceutical companies are required to comply with new drug production standards this year. The Narendra Modi government, under pressure since 2022 due to deaths linked to Indian-made medicines in several countries, has decided to closely monitor pharmaceutical factories to improve the reputation of the country's $50 billion pharmaceutical industry. The new directive states that drug manufacturers must accept responsibility for the quality of pharmaceutical products and ensure that they are suitable for their intended use, comply with the issued licensing requirements, and do not expose patients to risks due to safety, quality, or insufficient efficacy. Companies are also required to market the final product only after receiving 'satisfactory results' from ingredient testing and having sufficient samples of intermediate and final products for repeated testing. The Indian Ministry of Health announced in August that inspections of 162 pharmaceutical factories since December 2022 showed that raw material testing had not been conducted. According to this report, less than a quarter of the 8,500 small pharmaceutical factories in India meet the international drug production standards set by the World Health Organization. The directive states that the concerns raised must be addressed within six months by large companies and within a year for small manufacturers. Small companies have requested an extension of the deadline and warned that the necessary investments to comply with these standards could lead to the closure of half of them. The World Health Organization and other health officials have linked Indian cough syrups to the deaths of at least 141 children in Gambia, Uzbekistan, and Cameroon. Some drug production experts previously told Reuters that sometimes individuals replace propylene glycol with toxic substances such as ethylene glycol and diethylene glycol simply because they are cheaper. Such substitutes are more commonly used in brake fluid and other products not intended for human consumption. The World Health Organization suggests that in 2021, when the price of propylene glycol rose, one or more suppliers may have mixed cheaper toxic liquids with legal chemicals. The existence of an unclear supply chain has made it difficult to prove this theory, and drug manufacturers, including those producing contaminated syrups, typically source ingredients from foreign suppliers. It is unclear whether this cough syrup made its way to the Iranian market, but a shortage of common medications in Iran for some time led to items such as antibiotics, acetaminophen, and children's medicines becoming unavailable, prompting the Ministry of Health to urgently import from India. The ministry imported 50 tons of antibiotics from India. After announcing issues with some Indian antibiotics, Iran's Food and Drug Administration stated: 'After the urgent import of these drugs and during the conducted tests, it was determined that the drugs in question lacked an acceptable active ingredient and must be withdrawn from the market.' The Vice President of the Iranian Pharmacists Association stated that the imported drugs were not problematic but 'it would have been better if they had not entered the market before all tests were completed.' An official from a pharmaceutical company in Iran, who wished to remain anonymous, previously told Voice of America that the issue of drug oversight in Iran is more concerning regarding drugs that enter illegally and do not undergo testing. According to this official, other imported drugs are tested by the Food and Drug Administration. According to statistics provided by Iranian media, the value of India's drug exports to Iran was over $205 million in 2020, which decreased to $59.14 million in the 2023 fiscal year, attributed to 'the decrease in Iran's rupee reserves due to sanctions.' This report utilized sources such as Reuters, Associated Press, and Iranian media.