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.
