A public health-centred approach and a more nuanced interpretation of patent laws meant that India could allow its companies to reverse engineer many pharmaceutical formulations, thereby drastically reducing costs. The country came to be known as ‘pharmacy of the developing world’, a badge it wears with great pride. The positive interventions made through the help of Indian pharma companies to bring down the cost of treatment of Human Immunodeficiency Virus (HIV) infections in Africa, is considered legendary in public health circles. Though they drew the ire of international behemoths, Indian companies like Cipla and Sun became dark horses in an industry which is kept on a tight leash of regulations globally.
This success spawned many smaller firms, which increased the competition and brought down the prices of drugs further. This high availability of drugs at relatively small prices coupled with a poor implementation of regulations in retailing, meant that drugs like antibiotics were available freely. No antibiotic prescriptions were needed to get antibiotics from your neighbourhood pharmacy, and these potent formulations were sold sometimes as casually as biscuits.
The rampant availability and use of antibiotic in various sectors, both human and non-human, has contributed to the problem of Anti-Microbial Resistance, in which many microorganisms became resistant to these antibiotics. Use of some antibiotics became redundant, as continuous exposure to these antibiotics made the organisms acquire mechanisms to fight back. Reports are coming in from various regions of the country that the presence of drug resistant bacteria is increasing daily, with conventional antibiotics being made useless. A major contributor to the problem is the ubiquitous availability of antibiotics as a result of unregulated ‘over-the-counter’ sales.
The government of India has realised the gravity of the problem and has adopted a multi-pronged strategy to ensure that the country does not get renamed as ‘the hub of drug resistance to the developing world’.
The Red Line Campaign launched by India has made the use of a solid red line mandatory on the blister packs of prescription-only antibiotics. The red line is aimed at creating awareness among end users that the medicine they are buying is potentially harmful, if used without supervision of a qualified medical practitioner. The Red Line Campaign, which was launched last year, has been lauded by international experts for its progressive nature as the ‘punitive’ component in this landmark rule is very minimal. Apart from labelling of blister packs, the campaign also involved a major information push which tried to educate users on the meaning of the red line and dangers of indiscriminate use of antibiotics. Though it is quite early to comment on the impact of the campaign, it has been extremely beneficial in terms of highlighting the problems of antibiotic resistance especially among medical practitioners and chemists.
Another huge initiative which is slowly taking shape is the proposed e-platform to regulate the supply of drugs and to ensure that quality is maintained across the supply chain. A secondary objective of this proposal is to counter the growing threat of Anti-Microbial Resistance in India. As per the proposal, which will probably come into effect along with the implementation of Goods and Services Tax (GST), all establishments engaged in selling pharmaceutical formulations are legally required to be registered under an e-portal. The e-portal will be developed and maintained by an autonomous body, and all details of drugs sold, like quantity and batch numbers, have to be uploaded into the portal. Though the association of chemists are up in arms against the proposal citing the need for internet connection and lack of qualified medical practitioners in rural areas, the proposal can have far-reaching impact as there will be an ‘audit-trail’ for tracking the sale of antibiotics.
The National Action Plan on Anti-Microbial Resistance, which was developed by the Ministry of Health and Family Welfare with assistance from the World Health Organisation, lays down optimal use of antibiotics as one of the six strategic priorities. It calls for the strengthening of national regulatory authorities for ensuring quality and safety of antimicrobial drugs, more inter-sectoral coordination with reference to optimal antibiotic use and establishment of a national surveillance system to monitor antibiotic use. The policy document also calls for registration of all manufacturers, suppliers and sellers, apart from a monitoring system for antibiotic use in various sectors.
With a nation of India’s size and scale, how much of the policy will get translated to actual action is always a pertinent question. But it is heartening to know that the country has taken a few baby steps towards curbing the massive over-the-counter sales of antibiotics and thereby limit the spread of antibiotic resistance.
Dr Philip Mathew is the Executive Director of Centre for Environment, Sustainability and Health (CESH), and a public health consultant
Disclaimer: The views expressed in this article are solely those of the author and do not necessarily represent the views of the publication.
