India’s Problem with Medication Is Unregulated “Innovation”

If India is the world’s pharmacy, it isn’t doing a good job of offering secure goods. Children in the Gambia have lately passed away after consuming cough medication prepared in India in significant numbers. Additionally, 11 kids in India’s Jammu region perished in the same way in 2019. An industrial solvent called diethylene glycol was present in the cough medicine.

Because of the nation’s lax drug regulations, India and the rest of the world face a number of issues in addition to counterfeit and subpar medicines.

An urgent issue is a rise in antibiotic use in India, where misuse and overuse are major factors in the emergence of antibiotic resistance. The rate of antibiotic resistance in India is among the greatest and is reportedly increasing by 5% to 10% annually. In 2019, antibiotic resistance directly contributed to the deaths of almost 1.3 million individuals.

The high consumption of antibiotics in fixed-dose combinations is particularly concerning (FDCs). These medications come in a single dosage form and combine two or more medications in a specific ratio of dosages.

FDCs work well for treating some illnesses, including HIV and tuberculosis. The Central Drugs Standard Control Organization, India’s primary drug regulator, has not given its approval to many of the antibiotic FDCs sold in the country, and their effectiveness is unknown.

Unauthorized and possibly inappropriate FDCs are an oddity of the Indian environment. FDCs, according to the firms, are novel and ensure compliance by mixing several medications into one pill for patients’ convenience.

However, the dangers and advantages of these novel FDCs are unknown, given the absence of clinical trials demonstrating their efficacy and safety. This uncontrolled “innovation” poses a serious risk of accelerating the spread of antibiotic resistance.

The WHO is so concerned about the issue that it has listed antibiotic FDCs that it urges doctors not to prescribe and has categorized antibiotics according to their influence on antibiotic resistance.

The Indian government has a national strategy on antibiotic resistance and has launched a number of steps to combat the selling of FDCs without central regulator approval. In order to encourage rational prescribing and prioritize the use of medicines, it also has a national list of necessary medications. These activities date back many years. But the issue of hazardous and unauthorized medications still exists.

India purchases the majority of its pharmaceuticals from the private sector. Our most recent analysis of the private sector sales of antibiotics (those administered orally, intravenously, or through injection) in India in 2020 revealed that a third is in the form of FDCs. We discovered that the drugs the WHO has classified as not recommended and that are not included in the nation’s list of essential medicines are a major contributor to these sales. It would be more effective to provide well-supported FDCs, such as those on the list of essential medications, to patients in India.

Additionally, we discovered that 278 of the 395 (about 70%) antibiotic FDC formulations released in India in 2020 either lacked a record of central regulator approval or were outlawed. These results show that India’s drug laws require a complete revision.

The intricacy of the frequently modified drug laws, which stretch back to 1940 and divide authority between the federal and state governments, accounts for a significant portion of the issue.

While the states issue manufacturer licenses, the center is in charge of ensuring the efficacy and safety of new medications. However, the states have been issuing licenses to producers of FDCs even though they lack the necessary prior central regulatory clearance.

The issues of unapproved and unsafe medications and rising antibiotic resistance will not be resolved unless India enacts laws to ensure that all FDCs are centrally approved after meeting the requirements of safety and effectiveness, ensure that non-approved drugs are taken off the market, and prosecute makers who break the law. In order to guarantee that there is international confidence in India’s pharmaceutical industry, urgent legislation and stringent enforcement of the laws are required.