Expanding access

The Coronavirus pandemic has brought the deficiencies in our public health system to the forefront. Access to medicines and that too at reasonable prices is fundamental to ensure universal health coverage, enhancing the quality of life and resultant longevity.

India is described as the 'pharmacy of the world', but Indians themselves do not have adequate access to quality medicines at affordable rates. Article 47 of the Directive Principles of State Policy enshrined in the Indian Constitution lay adequate emphasis on the role of the state to improve the public health system.

The intellectual property rights in India allow the drugs and processes to be patented allowing the patentee monopoly rights for a given period. After the expiration of the patent duration, the drug can be freely produced by any company helping in reducing the prices of these drugs known as generic medicines. Generic medicines are equally effective as their branded counterparts and are on average 30 per cent-85 per cent cheaper. India is the largest producer of generic medicines worldwide and occupies a 20 per cent share in the global supply of generic medicines by volume. Moreover, the micro, small, and medium enterprises (MSME) dominate the Indian generic market, therefore, employ hundreds of thousands of persons.

With 1/3rd of the country's population living in poverty, India has one of the highest pocket expenditure on medicines and healthcare. India must take advantage of low priced generic medicines. Recognising the twin benefits of generic medicines to society, the Government of India started the 'Jan Aushadhi' initiative in 2008 for better access to generic medicines. However, so far only about 4,100 Jan Aushadhi Kendras could be made operational, although there are eight lakh retail pharmacies. The Government has also issued directions making it mandatory for doctors to prescribe generic medicines. It is also essential to display generic medicines in retail stores prominently and conspicuously.

The profit margin in the case of branded medicines is many times that for generic medicines. The medical representatives of these companies upscale their sales by sheer money power which is not possible for MSMEs which produce generic medicines. Also, there is deficient regulation for the manufacturing of generic medicines resulting in difficulty to verify the bioequivalence of generic medicines.

The United States Food and Drug Administration publishes the Orange Book listing all the approved generic medicines besides the trade name, ingredients and also verifies the therapeutic equivalence of the medicine. In India, the Central Drugs Standard Control Organisation (CDSCO) which is the nodal agency for regulation of manufacturing of generic medicines does not provide any such database that leads to low confidence of people in all generic medicines even if these medicines are effective.

On lines of the Orange Book published by USFDA, USA, a list of all generic medicines available in India can be created and be given wide publicity through different electronic and print media. This will improve the confidence of doctors and patients in generic medicines.

Access to quality and effective medicines should not be limited by the purchasing power of an individual. This wall of haves and have nots has to be broken starting from within the Government. The Central Government Health Scheme (CGHS) run by the Government of India and similar schemes operationalised in the state governments for its officers and employees, including elected representatives like MPs, MLAs, and MLCs.

There are more than 25 million serving government employees in addition to an equal number of retirees who are entitled to free medical treatment in the government hospitals or the hospitals empanelled by the state government or the Central Government as the case may be. The medicines are either supplied through government dispensaries procured by the medical health department or the medicines are purchased by the patient and reimbursed by the Government.

Can we think of evolving a system whereby the procured medicines by the government agencies are generic only and if purchased by the patient then only the reimbursement is capped to the price of generic medicine if the same is available?

It would serve two-fold purposes; one, it will help the Government in saving money on account of medicines; two, since the government servants shall be purchasing medicines, it will lead to better checks on their quality aspects.

The pharmaceutical industry is also overly dependent on China for its raw material, that is, APIs (active pharmaceutical ingredients). At present, almost 70 per cent of the APIs in India are sourced from China. Keeping in mind China's aggressive and opportunistic behaviour, a blockade on exports of APIs to India could pose a major national security threat. Despite having the capacity and capability to manufacture APIs, the Indian industry cannot compete with the artificially low prices supported by the Chinese Government.

Atma Nirbhar Bharat must address the problems faced by the pharmaceutical industry. The Coronavirus vaccines researched, developed and manufactured in India are a testament to India's capability and capacity.

The writer is a research scholar at JNU. Views expressed are personal