Express Pharma

The dominance of trade in health

Reflecting that the recent accident in Gambia should be a wakeup call for Indian pharma companies, Dr Suresh Saravdekar, former Assistant Director, Ministry of Medical Education and Health, State of Maharashtra, and Honorary Consultant, Institute of Medical Sciences- BHU, Varanasi, points out how gaps in India’s pharma regulatory system need to be plugged

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Medicines are life savers. So, it is a general expectation that there should be a uniform standard anywhere in the world and the general public feels that this should be the case. But there is a big difference between what we feel and what reality is.

It is a fact that the quality of medicine sold globally is not the same across countries; in fact, not even at the domestic level. While this situation is not known to the patients, most doctors too could be ignorant of this fact.

It is a harsh reality that different-quality medicines are produced all over the world, and the drivers of quality are not the doctor’s or patient’s needs, but the economic and technical capacity of the country.

This fact goes unnoticed for years, until occasional incidents, like in July 2022, when 70 children died in Gambia, once again uncovered the supply of substandard medicines in poor countries. These deaths of poor children happened due to low-cost cough medicine imported from India. The World Health Organization (WHO) subsequently declared the medicines of substandard quality and banned its use all over the world. The Indian drug control administration woke up, but only after this declaration at the international level, and patted itself on the back, saying ‘’Good. This medicine was not supplied in India.’’ What duplicity!!

Quality and safety
Globally, the automobile industry is primarily developed based on technology researched in Europe and Japan. Consequently, when it comes to the safety standards for car manufacturing, cars from Europe are the ‘’safest’’ followed by those from Japan.

Secondly, based on the technology of these countries, cars are manufactured in other countries including India, where suitable and minimum technology base is available. However, when you consider the safety of cars manufactured in these secondary markets, by using secondary technology, the safety of these cars is at its lowest; since these countries aim to provide cars at affordable prices, so that maximum people can afford to buy these cars.

Global research on medicines and dominance of rich countries
It is the same case with research in medicines. In this context, it is worthy to note the findings of the WHO reports on the Situation of Medicines (2007-2012) and Access to Medicines (May 2019).

◆ New techniques and new products are being developed, and are being marketed world over, still, many product gaps and delivery challenges remain unmet.
◆ Because the priorities in research are not “need-based’’ but “market-based’’
◆ Consequently, the “scale of the development’’ does not match the “scale of people’s need’’ for better access to medicine, particularly in Low Income Countries (LICs) and low-income groups in Middle Income Countries (MICs).

Thus, the main drivers for industry engagement in research are trade, and not health needs. Consequently, medicines are invented for the “few diseases” and for “few countries,’’ where there is a sizeable global market. Naturally, during the last 50 years,hardly any new medicine has been invented for diseases likemalaria, dengue, leptospirosis and AIDS, which are prevalent in Low Income Countries (LICs). In general, the development of new drugs is market-driven and has little to do with rare diseases in the developed countries or serious tropical diseases in the developing countries.

Beyond research, concerns about the safety of people in rich countries seem higher as accidents spur higher quality standards to accommodate the latest safety measures, which are strictly followed. But that ‘’urgency of updates’’ in safety standards is not felt necessary by other countries. This brings us to the present situation of having three broad quality and safety standards observed the world over.

Global market and situation of the quality of medicines

Highest standards of quality with safety at the top: Medicines of this quality are updated and improved in terms of safety standards, and are manufactured using the latest manufacturing technologies which are updated to check entry of all possible impurities in the medicine, at the API (Active Pharmaceutical Ingredient) level and through faulty procedures of manufacturing. This is called “cGMP (current Good ManufacturingPractices) Quality Standards” of medicines. They are manufactured, used and exported from rich countries and other technologically advanced countries.

Medium standards with medium safety: These export standards are world-class and technically updated every two years in terms of safety. Such standards of manufacturing are called ‘’WHO GMP (World
Health Organization–Good Manufacturing Practices) Quality Standards’’ of medicines, and are exported from technologically advanced countries to non-technologically advanced countries.

The minimum standards with the lowest safety: Such medicines are not manufactured as per the WHO GMP standard. Hence, standards are not updated every two years, but updated randomly, mostly when accidents occur. These quality drugs are used in countries like India, Brazil, etc., which are supplied as generic and brand medicines in the domestic market and also exported to technologically- and economically-weaker countries like Gambia, Nigeria, Yemen, etc., where even basic standards for checking the quality of drug facilities are not available.

Indian pharma industry

Indian pharma industry is technologically better placed, and has huge manufacturing base among developing countries. It is, therefore, considered as the “Pharmacy of the World.” This s