Why in news?
- Indian government may bring in a legal framework under which doctors will have to prescribe generic medicines.
- It is the Government’s responsibility that everyone should get health services at minimal price.
What is the importance of the issue?
- It is a noble intention and indeed the responsibility of the government to make healthcare accessible and affordable to all.
- A landmark act introduced in the US in 1984, “the Drug Price Competition and Patent Term Restoration Act” transformed the drug market in that country by allowing a generic medicine.
- The generic drug would not have to undergo a complete clinical trial to be proved equivalent.
- Subsequently, this model has been followed in other countries and today most OECD and other developing countries accept the substitution of a branded medicine with a generic equivalent.
What is the need for a regulator in Drug industry?
- The argument is that the need for a muscular drug regulatory authority (DRA) is far more urgent.
- The DRA should serve the dual purpose of making the rules simpler yet stricter, while having the required resources to enforce them effectively.
- Every drug manufacturer should publish details of its manufacturing facilities, specifications, capacity, certifications, all subsequent inspection reports to a central portal.
- Products should be approved as generics based on whether they are pharmaceutically equivalent, bio-available, and bio-equivalent.
- All new products or new combinations of existing products should be subjected to a more extensive clinical study to prove safety as well as effectiveness.
- Facilities which do not comply with GMP (Good manufacturing Practice) should be immediately barred from production until such compliances are in place and products made in such a facility should be immediately recalled.
- All products should be tagged with a unique RFID, barcode or such similar identification to ensure traceability from manufacture to consumption.
- Generics should be labelled and sold as such in order to prevent a brand to brand substitution rather than a brand to generic substitution at the retail level.
What are the steps taken by the government?
- The Ministry of Health and Family Welfare proposed the setting up of an e-portal to track and regulate the sale of drugs across the retail chain.
- The aim was to prevent the sale of fake and substandard drugs, which are estimated to account for a substantial share of India’s drug market.
- The Ministry’s proposal to bring both traditional and e-pharmacies under the ambit of the e-portal to track drugs is a welcome move.
- It has mandated that e-pharmacies must set up a “licensed brick and mortar facility” as part of their operations to comply with the new regulations.
What is the way forward?
- The risks associated with e-pharmacies, especially when it comes to the dispensation of prescription drugs without the necessary checks, cannot be taken lightly.
- The Ministry’s plan on regulating e-pharmacies is a rather outdated one.
- This seems like an indirect way of delegitimising the business model of e-pharmacies, rather than a regulation that aims to improve their transparency and regulation.
- The huge potential for e-commerce in the retail drugs industry is enough reason to avoid such unreasonably stringent standards.
- Enforced with punitive fines for non-compliance, the new measures will not only make medicines affordable to all, but also give the customers the choice without fear of compromising the quality of their care.
Source: Business Line
