The government has made significant strides in improving healthcare access. However, the National Medical Commission or NMC’s decision to enforce generic drug prescriptions under penalty raises concerns about quality assurance, availability gaps, and the government’s stance on branded generics.
The government has made great strides in improving healthcare access in recent years. The Pradhan Mantri Jan Arogya Yogana (PMJAY) Ayushman Bharat health insurance plan, which serves 400 million of India’s 1.4 billion people, is a key endeavor. The government’s careful control of NLEM pharmaceutical pricing has also reduced medicinal prices. However, the National Medical Commission’s (NMC) recent decision to enforce generic drug prescription by doctors under penalty impacts patients’ right to choose, medical practitioners’ right to provide the best option, branded drug makers’ right to manufacture assured quality medicines, and the overall healthcare landscape’s ability to improve affordable quality medicine.
Concerns about quality
The NMC rule ignores quality issues. Lack of generic pharmaceutical quality access is the main concern. Doctors lack knowledge about manufacturers and quality checks before end-users. However, branded generics provide assurance due to their genuine origin. Doctors know the targeted goals, source, firm, and promoters, which provides proof and confidence. These firms have manufacturing licenses. The government’s opposition to branded generics raises issues about their legal production licenses. Generic medicine quality assurance in India is insufficient and might harm patients. The NMC claims its regulation will lower healthcare costs, but patients could never improve their access to quality generic medicines because doctors never wanted to negotiate on quality and patients’ lives should be prioritized. The best friend of a patient is healthy competition, which is absent nowadays. Instead of reducing options and regulating monitoring on quality medications in the supply chain to help consumers afford healthcare, we will create scarcity and raise prices.
NMC rule is unneeded and premature, in my opinion. A complete quality law must handle generic, branded, and proprietary drugs equally. Quality assurance must be equal for everybody, not only special for the privileged. Uniform quality in the Indian Pharmacopoeia gives patients trust in medicinal efficacy. Poor patient confidence depends on the doctor. Doctors cannot be forced to prescribe without conviction. Doctors must have all information regarding generics’ quality, effectiveness, and results before recommending them.
Manufacturer qualifications, batch sample retention, NABL lab testing, and WHO GMP compliance are relevant questions. Physicians care about patients and can examine the regulation’s reasoning. Government regulation won’t be universally accepted.
For a branded medicine prohibition, the government should compensate producers. Instead of closing non-compliant enterprises, a system should improve their quality views according to global best practices, assuring compliance with top standards. Plant closures scare customers with medicine shortages and price spikes. Of course, willful fabrication of bogus and Not-of-Standards-Quality (NSQ) should be punished and deterred to protect people.
Law demands GMP and Schedule M compliance in pharma production regardless of firm size. Schedule M of the 1940 Drugs and Cosmetics Act is non-negotiable for pharmaceutical firms. Once licensed, MSME pharma enterprises cannot allege size-related Schedule M noncompliance.
Availability gaps
The NMC ignores availability. Will the drugs be available? Despite government buying, Jan Aushadhi stores don’t carry all NLEM drugs. Jan Aushadhi failed to ensure quality through government monitoring. Jan Aushadhi outlets have risen, but supply chain gaps remain a problem for the Department of Pharmaceuticals. Due to opaque quality assurance methods, drug quality problems exist.
The report was ignored despite spending Rs 8.5 crore of government money on a research and gathering 47,000 supply chain samples. It revealed procurement system weaknesses in government-sourced medications with 10% quality faults. However, the government promotes generic use exclusively. Plain generics for the public must meet the quality of branded and export generics, according to the government. We cannot tolerate double standards as patients.
Vital is generic drug availability. The government claims affordability, yet supply capacity is insufficient. Despite PLI initiatives and API manufacturing financing, the pharma sector imports. The government must provide solid guarantees, not just words. Ordinary individuals depend on subsidized medications and medical prescriptions, requiring more than vague guarantees.
The way forward
Drug production quality should be the priority regardless of patient affluence. Manufacturers must ensure cutting-edge quality, face fair market competition, and provide medical practitioners and patients choice regardless of cost. How can the government expect the Pharma industry to function at global standards if certain medication companies compromise quality? Why can’t local medications match export quality? We are the Pharmacy of the World, and as a leading global generic drug provider, India must first provide its inhabitants with world-class goods. The government should address these concerns instead of banning branded generic medications.
Conclusion:-
The government has made significant strides in improving healthcare access, such as the PMJAY Ayushman Bharat health insurance plan. However, the National Medical Commission’s (NMC) decision to enforce generic drug prescriptions under penalty raises concerns about quality assurance, availability gaps, and the government’s stance on branded generics. The NMC rule ignores quality issues, and a complete quality law must handle generic, branded, and proprietary drugs equally. The government should compensate producers and improve their quality views according to global best practices, as well as enforce Schedule M compliance in pharma production. The government should prioritize drug production quality, face fair market competition, and provide medical practitioners and patients choice regardless of cost.
