Regulatory Measures and Potential Challenges:
The draft Drugs, Medical Devices and Cosmetics Bill of 2023 aims to regulate, restrict, or even ban the online sale or distribution of drugs through notifications. However, this proposal might pose challenges for online pharmacies in India as it could potentially limit their operations.
Quality and Safety Concerns:
The Drugs Controller General of India (DCGI) has issued notices to major online drug sellers, including Amazon and Flipkart Health. The concern stems from potential misuse of drugs due to self-medication or improper usage. The absence of proper licensing and oversight in the online sale of drugs could impact the quality and safety of medicines, posing risks to public health.
Opposition from the Medical Community:
The All India Organisation of Chemists and Druggists (AIOCD) and senior members of the Indian Medical Association (IMA) have voiced concerns. They worry about the misuse of prescriptions, lack of quality control, and insufficient monitoring of adverse effects. There's also apprehension that drug cartels might exploit doctors to reauthorize prescriptions for patients they've never seen.
Violation of Laws:
The Indian Medical Association's white paper has highlighted that the online availability of prescription drugs contradicts various laws, including the Pharmacy Act of 1868 and the Drugs and Cosmetics Act of 1940. The sale of restrictive drugs, like Schedule H and Schedule X drugs, without proper checks, goes against established guidelines.
Impact on Public Health:
Government officials are alarmed by the potential promotion of drug abuse, misuse, and self-medication facilitated by online pharmacies. Concerns about the rampant misuse of antimicrobial agents leading to antimicrobial resistance have been raised. Additionally, the risk of polypharmacy resulting in health hazards for consumers is a pressing issue.
Calls for Formalizing Rules:
Industry bodies such as NATHEALTH and FICCI have sought discussions with the government to address concerns and provide support in establishing long-pending regulations for e-pharmacies.
In conclusion, the government's draft bill seeks to tackle issues linked to the online sale of drugs, particularly prescription medications, through regulatory measures. However, this move has encountered resistance from industry stakeholders and the medical community. Concerns regarding drug quality, public health implications, and legal violations have been brought to the forefront. The ultimate decision on the bill's implementation is pending, with stakeholders closely monitoring the situation.
