AN URGENT PRESCRIPTION
Important points to be noted in this article are as follows :
Why has this issue cropped up ?
India is rightly acclaimed to be the pharmacy of the world, with its huge private sector capacity for producing generic drugs. However, there has been a decline and near disappearance of public sector capacity for manufacture of drugs and vaccines. That is a cause for worry.
Significance of public sector
• 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.
• 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.
• With the acquisition of Indian drug companies by foreign manufacturers, public sector capacity for manufacturing life saving drugs under a CL is the much needed fall-back option.
• Drugs for neglected tropical diseases are of little interest to the commercially driven private drug industry
Compulsory licensing
• Compulsory licensing 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.
• 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. This appears to have dampened the appetite of private drug manufacturers to avail of the CL route for the manufacture of generic versions of the new anti-tubercular drugs.
Way forward
• If the domestic private sector drug manufacturers are not ready to apply for CL, for whatever reason, public sector capacity to seek and utilise such licences becomes indispensable.
• 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 import.
• National security demands that we develop both public and private sector capacity within the country, with suitable government support and incentives, to ensure uninterrupted and inexpensive availability of APIs.
• The High Level Expert Group Report on Universal Health Coverage for India (2011) clearly articulated the need for strengthening public sector units (PSUs) which have drug manufacturing capability.
• 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. The existence of PSUs would also provide an opportunity to utilise the provision of Compulsory Licensing under TRIPS.
• Effective implementation of the Ayushman Bharat initiative calls for investment in expanding public sector capacity for producing essential drugs and APIs, even as the domestic private sector is incentivised to offer quality assured generics at a lower cost through a policy of pooled public procurement. This also embodies the spirit of Make in India.
Conclusion
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.
Relevance : GS 2
Try this probable Mains question
India is considered as the pharmacy of the world and yet the poor in India have little access to essential drugs. Comment [ 200 words]
