Banned yet available - The paradox of restricted medicines in India

In recent times, the safety of commonly used medications in India has come under scrutiny. A notable case is the restriction of certain cough syrups, particularly those containing dextromethorphan, following reports of adverse reactions and deaths in children. In response, the Indian government has taken steps to regulate these medications more strictly. However, this raises a broader concern: why do banned or restricted medicines continue to be used despite official prohibitions?

1. Banned and restricted medicines in India

Over the years, the Indian government has prohibited several drugs and fixed-dose combinations (FDCs) due to safety, efficacy, or ethical concerns. Some notable examples include:

* Nimesulide: An anti-inflammatory drug banned for use in children due to liver toxicity risks.

* Rofecoxib and valdecoxib: Non-steroidal anti-inflammatory drugs (NSAIDs) withdrawn globally for cardiovascular risks.

* Phenylpropanolamine: An appetite suppressant linked to increased stroke risk.

* Codeine-based cough syrups: Banned for pediatric use due to potential respiratory depression.

* Analgin (Metamizole): Banned for human use in India due to agranulocytosis risk.

Despite these bans, reports indicate that some of these drugs are still available in the market. For instance, a study highlighted that banned drugs like Nimesulide and Phenylpropanolamine are still marketed in India due to lack of law enforcement and physician awareness.

2. Reasons for banning or restricting medicines

The Indian government bans or restricts medicines based on:

* Safety concerns: Drugs that pose significant health risks, such as liver failure, cardiovascular events, or agranulocytosis, are withdrawn from the market.

* Lack of therapeutic justification: FDCs that do not offer additional therapeutic benefits over individual components are prohibited.

* Global withdrawals: Medicines banned in other countries due to safety or efficacy issues are often banned in India to align with international standards.

3. Reasons for continued use of banned medicines

Several factors contribute to the continued use of banned or restricted medicines:

* Regulatory gaps: Inconsistent enforcement across states and regions allows banned drugs to remain in circulation.

* Lack of awareness: Both healthcare professionals and the public may not be fully aware of the bans or their implications.

* Stockpiling: Existing stocks of banned drugs may continue to be used until depleted.

* Online sales: The rise of online pharmacies can make it easier to access banned or restricted medications.

* Economic factors: Cheaper alternatives may drive the continued use of certain banned drugs.

4. Legal provisions governing drug bans

The primary legal framework governing drug bans in India is the “Drugs and Cosmetics Act, 1940, and its associated rules. Key provisions include:

* Section 26A: Empowers the central government to prohibit the manufacture, sale, or distribution of drugs that are found to be unsafe or ineffective.

* Schedule H and H1: Lists drugs that require a prescription for sale, aiming to control the distribution of potentially harmful substances.

* Schedule X: Includes drugs that are considered to have a high potential for abuse and are subject to stricter controls.

5. Measures for effective Implementation

To ensure that banned and restricted medicines do not remain in circulation, the following measures are recommended:

* Strengthening enforcement: Regulatory bodies should conduct regular inspections and audits to ensure compliance with drug bans.

* Public awareness campaigns: Educating healthcare professionals and the public about the risks associated with banned drugs can reduce their use.

* Monitoring online sales: Implementing stricter controls on online pharmacies can prevent the sale of banned medications.

* Encouraging reporting: Establishing mechanisms for reporting violations can help in timely identification and action against illegal drug sales.

While India has made significant strides in banning drugs that pose health risks, the continued use of these medications highlights gaps in enforcement and awareness. By strengthening regulatory measures and educating the public, India can better protect its citizens from the dangers associated with banned and restricted medicines.