India needs to develop an agile national medicines & vaccines procurement and supply agency

Dr Dileep Mavalankar, Director Indian Institute of Public Health Gandhinagar & Dr Payal R Kumar, Independent Researcher stresses on why agile national medicines & vaccines procurement and supply agency is the need of the hour

The first and second wave of COVID in India showed how important is the medicine procurement and managing the medical logistics supply chain was. Many medicines like Tocilizumab, Remdesevir and supplies like oxygen were in acute shortage in the second wave in April- May 2021. The situation became worse as the Mucormycosis disease developed as complication of COVID. There was acute shortage of Lipophilised Amphotericin B and other drugs. In any scarcity situation there is always a likelihood of hoarding and black-marketing, since people who are in dire need of the medicine   any price to save their near and dear ones. At times, some unscrupulous elements in the society and supply chain would go to the extent of manufacturing fake drugs and sell them clandestinely to make quick money. All these things happen when there is weak regulatory and compliance mechanism in a vast country like India. As has been reported in media, many such instances occurred during the second wave of covid at various places in India and people suffered as a consequence.

As far as public health facilities are concerned, government agencies procure medicines, vaccines and other medical equipment for national health programs such as RCH, TB, Malaria etc and distributes to the states/districts. For general medical needs of primary, secondary and tertiary care, the state agencies procure medicines. The new drugs and vaccine are approved by DCGI at national level. In emergency situation the DCGI approves vaccines and drugs for “emergency use authorization” for limited time.  Normally the drug controllers of various countries including India have to be very cautious and have to follow detailed and stringent procedures to ensure that medicines and products which have major side-effects or un-proven efficacy do not enter the market. Hence the procedures set for introduction of new drugs are very stringent, with procedural requirement for lot of safety and efficacy data to be provided by the manufacturer. To assist the regulator, there are various Subject Expert Committees (SEC) that review the voluminous data and then make technical recommendation. In normal non-pandemic times such procedures are desirable and also well defined. But in times of pandemic such conservative processes take lot of time and can substantially delay the approval of new drugs and vaccines. This seems to have happened in many parts of the world and also in India to certain extant during COVID pandemic.

Secondly, by default and by design most of the regulators are normally reactive rather than pro-active – i.e., some manufacturer of the drug or vaccine needs to apply for approval and then only they can take up the scrutiny and evaluation of the product. In a pandemic like situation, many big international companies making such specific drugs and vaccines may have lot of orders for their products globally and hence may not bother to apply for license to India as the India market prices are much lower than international market prices hence the companies may want to sell their products in more developed markets. This also puts India and other developing countries at a disadvantage in a pandemic. During current pandemic Government had created a special mechanism through Task Forces and Empowered Groups on various themes, to manage the emergency situation on almost all aspect of pandemic management. These Task Forces and Empowered Groups dealt with various aspects of pandemic management including vaccine, drug procurement and ensuring timely supplies. Creation of such Task Forces and Empowered Groups is indicative of a need to create a long term and structured mechanism for drug development and procurement.

Thirdly, the drug regulatory agencies have no proactive mechanisms to estimate demand of the drug in India and proactively look for supplies internationally. They are generally tuned to grant approvals and regulatory work. Hence when the COVID struck our national agencies could not react fast enough to approve new drugs and vaccines and Government had to innovate and institute the mechanism of Task Forces and empowered Groups as interim and ad hoc mechanism. At times, the agencies could not accurately predict the demand of various drugs and equipment including medical oxygen and as a consequence there were shortages reported at various places especially during second wave. Therefore, we advocate that government of India should create a permanent institutional mechanism for a national level medical supplies monitoring and procurement agency. Such agency should conduct continuous need assessment, market surveys, study national and international supply chains and monitor the demand supply gaps of medicines and medical equipment on one hand and should coordinate with regulators on the other. This agency may act as union procurement agency for Government of India and an umbrella organization guiding the state level procurement agencies for efficient and effective supply chain management. Such a national medicines and vaccine agency will help meet the needs of the medical supplies for whole of India, especially in emergency or pandemic situation.

It should monitor the overall supply and demand situation of various vital and essential drugs in a pandemic situation and also during regular conditions. It will proactively review various internationally available drugs for diseases prevalent in India and estimate the demand in the country. They the agency will invite manufacturers to apply for authorization of those drugs in India. Such agency will also keep a watch on medical oxygen other critical supplies and medical appliances. The agency may also be empowered to commission cost effectiveness studies and technology assessment work. Such agency should have power to approve and procure medicines, vaccines and supplies on emergency basis during pandemics, epidemics and disasters.  Such an agency should be an interdepartmental agency with staff and functionaries drawn from ministries/departments like, Health and Family Welfare, Department of Pharmaceutical, Department of Bio-Technology etc.  It may be modelled either an authority though an Act of Parliament on lines of NDMA or an executive body through executive orders on lines of National Health Agency. Such a national agency for procurement and distribution of drugs and medical supplies will make our health system much more capable of responding to major pandemic and non-pandemic health challenges.  Given the recent experience of COVID pandemic the government is more likely to form such an agency if adequate advocacy is done at the right level.