An urgent prescription
- India needs it’s time to boost up public sector capacity for making medicines
- India is rightly acclaimed to be the pharmacy of the world, with its huge private sector capacity for producing branded and unbranded generic drugs.
- Public sector capacity for manufacture of essential drugs and vaccines is very much needed to ensure that our population is not denied access to drugs that the Indian private sector is unable to produce or supply at affordable cost.
- India opted for process patenting over product patenting in 1970.
- This changed to a product patent regime in 2005, providing sufficient time for growth of the generic drug industry in the private sector.
- However, this period has also seen the decline and near disappearance of public sector capacity for manufacture of drugs and vaccines.
- Compulsory licensing (CL) is a mechanism permitted by the Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement to enable countries to issue licences to domestic drug manufacturers to produce and market affordable generic versions of life-saving drugs needed for meeting serious public health challenges that are of extreme urgency.
- This allows countries to overcome patent restrictions to assure availability of such drugs when the situation demands.
Drugs effective against multi-drug resistant tuberculosis and anti-cancer drugs are clear examples of such a need, which should be addressed through compulsory licensing.
Global scenario in India:
- India has used the CL route previously to permit two Indian companies, Natco and Cipla, to produce a potent anti-cancer drug nexavar.
- This enabled a 32-fold reduction in the cost of the drug.
- However, extensive litigation followed with action initiated by Bayer, the multi-national manufacturer of the patented version.
Role of private sector:
- Drugs for neglected tropical diseases are of little interest to the commercially driven private drug industry.
- Active pharmaceutical ingredients (APIs), which are needed for drug manufacture (formulation), are now mostly imported from China.
- This makes India highly vulnerable to disruptions in supply and cost escalations in
- The report stated that the use of PSUs will offer an opportunity to produce drug volumes for use in primary and secondary care facilities as well as help in ‘benchmarking’ drug costs.
- Effective implementation of the Ayushman Bharat initiative calls for investment in expanding public sector capacity for producing essential drugs.
- It will boost our government in making India.
- By taking this matter seriously India should take the lead in ensuring universal access to affordable drugs through such measures.
- Investment in public sector capacity is essential to ensure that the country can exercise that leadership even on occasions when the private pharmaceutical sector does not fully align with that objective.