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

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 strength of good manufacturing capacity made India a major supplier of COVID-19 vaccines worldwide, and, especially to poor countries.

Secondly, the Indian generic drug manufacturers are offering the lowest price, because of availability of good technology and trained manpower at the lowest price.

In this background, the recent deaths of Gambian children are not only shocking, but also regrettable, and lead to suspicion about the quality of medicines made in India. Moreover, this clearly exposes our casual and callous attitude and shows that we do not learn from such accidents. Since, in the past too, there have been many such incidents, where the contamination of the amount of diethylene glycol in the medicine has resulted in deaths worldwide. To quote few tragedies in India, in 2020, in Udhampur (Jammu) 12 children lost their lives due to this deadly cough medicine. Past incidents include 1998 (33 children in Delhi area); 1986 (14 patients in Sir J J Hospital, Mumbai) and in 1973 (14 children in Chennai).

Various trade policies used in pharma manufacturing in India

The main reasons for manufacturing of substandard-quality medicines are as follows:
◆ Having regulatory permission to offer medicines with various quality standards as mentioned above of the highest-,medium- and the lowest-quality medicines
◆ Cutting the cost in order to quote the lowest price only to grab the tenders and
◆ Flexibility to use various types of drug licences, even permitting companies to only market medicines without manufacturing them.

The flexibility of using various licences, namely third party, loan licence and P-to-P (third-party manufacturing process which is exclusively used for one principal party) is being used by both purely marketing and by partly of manufacturing big companies in India to offer the medicines of various qualities at various prices as per the demand of the trade. The partly marketing companies do have their own manufacturing facility, but, in order to reduce their own production cost, these big companies buy the same drug cheaply from small companies on “third-party basis” and sell it under their own label at a higher price under brand name.

Apart from cost reduction, this facility of outsourcing of manufacturing is also used as a loophole in the law and as a scapegoat. When a drug is found to be substandard, the third-party manufacturer is prosecuted under law, and not the marketing company. Due to this, the big company escapes being penalised by simply shifting the blame to another third-party manufacturer, while it continues to enjoy its standard-quality status of brand even though it has lost.

In India, this has now become a common practice. These companies are now taking maximum cost advantage to their benefit, and, at the same time, easily escaping from the clutches of the law, simply by pushing the burden of standards of quality solely on the shoulders of the third-party manufacturer.

In this context, I would like to mention an incident that happened during my career. In 1986, due to supply of the poor quality of medicine, 14 patients died in the government-run Sir JJ Hospital in Mumbai. The Government appointed a Commission headed by Justice Lentin to inquire into the matter.

After this incident, I was transferred from Government Medical College, Nagpur to Grant Medical College to which Sir JJ Hospital is attached. I got a chance to study the recommendations of Lentin Commission Report, and, based on the report, we proposed to the Maharashtra Government that they should procure medicines only from a manufacturer observing international WHO-GMP standards and only those using their own manufacturing licence, rejecting companies resorting to third-party manufacturing.

The government accepted the recommendation. And, since 2003, Maharashtra, followed by some other states, started procuring medicines manufactured to international standards, in company-owned premises, and not out of third-party facilities. Since then, not a single case of supply of substandard medicines has been reported in Maharashtra government-run hospitals procured only under state rate contract.

International pharma trade, health and governance

It should be clear from the above discussion that there are many conflicting interests, ethical and other issues affecting the healthcare of each individual at local and global levels. Healthcare strategies and policies are developed based upon different approaches, influences and philosophies. The ultimate decisions affecting healthcare resource allocation rely on government policies and legislations, which are influenced by political groups, commercial interests, patient groups and other society groups, in general. In the end, there has been a dominance of trade over health while framing international policies, which has resulted in segmentation of the world by quality standards of medicines.

Global segmentation by quality of medicine

Globally, the economy and technological strength of a particular country determines the ability to procure standard quality medicines. This has resulted in the segmentation of countries into four levels.

Technologically weak, but economically strong countries and rich countries like Arab countries in the Middle East, import world-class drugs, but, while doing so, a certificate is taken from the exporting country that the citizens of that exporting country are using the same drugs. (Country of origin Certificate) as an assurance of good quality.

Countries, both, technologically and economically weak, such as African countries, have no choice, but to import medicines of minimum quality which are more affordable from countries that may not be as up to date with international standards of manufacturing medicines as they should be. Technologically weak, but economically strong South Asian countries import drugs of minimum quality standards from technologically strong countries like India, Brazil, etc.

Technologically strong and economically strong, but in terms of population, it is not economically affordable to produce medicine, such countries like Belgium, Netherlands, Norway in Europe and in Russia, import the world’s highest-quality drugs from the technologically-advanced countries of Europe and America.

Some solutions

How can we break out of this trap of international trade and save health?

As per my understanding, I propose that international bodies like WHO, etc. need to consider these actions. The processes of contemporary globalisation is creating ever-closer ties between individuals and populations across different countries. The health of a population and the systems in place to deliver healthcare are increasingly affected by factors beyond the population and health system.

A series of six articles published in The Lancet’s February 2009 issue takes stock of the link between trade and health, and provides an overview of these links among international trade, trade liberalisation
and health. The articles raised the following challenges and key issues that face the health community and provide timely analysis of the key challenges facing efforts to achieve an appropriate balance between trade and health across a diverse range of issues.

Main challenge: It seems the two international regulating bodies WTO and WHO are operating in isolation, with little cooperation between them, but increasing dominance of trade over health. Therefore,
currently, the main challenge to the public health community is how to position health more centrally in trade policy, to optimise opportunities to benefit health and healthcare, while minimising the risks posed. To do so requires better understanding of the key issues at the trade-health interface, seeking to engage with trade on a more equal basis, and taking the initiative in the presentation of health at trade fora.

Key messages
◆ Increased trade and trade liberalisation is a defining feature of globalisation, and will directly and indirectly affect health and health systems. However, evidence is needed of policy responses to mitigate
negative health effects, optimise health benefits, and distribute costs and benefits appropriately across different populations.
◆ There is a need for health officials, professionals and scholars to understand the key issues and to seek engagement with their counterparts within trade and international affairs to secure an appropriate
balance between the pursuit of health and trade.
◆ Action is needed to strengthen the substantive involvement of the WHO with international trade organisations like WTO. Although WHO’s influence comes from a range of sources, perhaps based on its technical expertise, but also including its global reach and historical legacy of respect among developing countries, there is undoubtedly a need to strengthen this in a more formal manner.

Actions needed at the national level
The recent accident in Gambia should be a wakeup call for Indian pharma companies. It is now necessary to improve the drug quality policy and raise the bar of quality standards to the global level. These are some gaps which need to be plugged immediately.

1. Global harmonisation of quality: It is necessary to make it mandatory for drug manufacturers to provide, manufacture and import-export medicines of the same highest quality all over the world
2. Stop the issue of licences for companies which are engaged in only marketing of medicines and abolish the “Outsourcing of Manufacturing” by big companies too. Or enact a law by which the marketing
company should also be equally held responsible, for prosecution and conviction along with third-party manufacturer for the supply of substandard medicines under the Drugs and Cosmetics Act.
3. There was a committee headed by Dr Mashelkar appointed by the central government. The committee was to discuss the circulation and consumption of spurious drugs in India, and to suggest a structure for a national drug regulatory system; and recommend measures to strengthen the drug regulatory infrastructure at the central and state levels, steps to be taken by the pharma industry to reduce the manufacturing of spurious drugs, as well as changes in the Drugs and Cosmetics Act, 1940. The committee submitted its report in November 2003, and had pointed out the following lacunas and forwarded suggestions.

◆ The problems in the drug regulatory system in India are primarily due to the inadequate drug control infrastructure at the central and state levels, insufficient drug testing facilities, and a shortage of drug inspectors and a lack of trained officials for specific drug regulatory activities.
◆ The Drugs and Cosmetics Act, 1940, is the primary legislation regulating the import, manufacture, distribution and sale of drugs in India. Its enforcement, the report states, has been inadequate in many states. A reason for this is that the law’s provisions have not been uniformly interpreted across the country.
◆ The Committee recommended that State Drug Control Organisations be strengthened with funds as well as “competent and trained personnel” for the effective regulation of drugs.) “Lack of Up-to-date Training”- Drug Controllers must be up-to-date with modern technology. At present, their training is organised at, and depends on the grace of a large technologically-updated companies. So, there is no doubt that such training will not be wholehearted, and only at the mercy of these companies.
◆ The penalty for the sale and manufacture of spurious drugs that cause grievous hurt or death, states the Committee, should be increased from life imprisonment to death. Offences related to the manufacturing and sale of spurious drugs should be made non-bailable.
Lack of fear of punishment: The current conviction rate is very poor. So, there is no strong deterrent to prevent the manufacturing of substandard medicine.

I feel two action points need to be added to this list – the prosecution under Drugs and Cosmetic Act should be immediately followed by filling an FIR by the police department. The current practice of only suspension of license is not sufficient. Secondly, some social compensation in the form of economic help should be given to the family whose member suffered the loss due to the death or injury because of consumption of substandard medicine.

To conclude it, if only trade is given importance, poor people’s lives will be always at stake, and they will continue to die due to the use of substandard medicine in countries around the world. In this regard, I would like to reproduce the recommendations of Justice Lentin and of the High Court Justice Lodha. Justice Lentin, who inquired in to the death of 14 patients in Sir J J Hospital and had categorically warned the government that in order to avoid such tragedies in future,

“Least priced drugs are not necessarily of the best quality. Hence, it must be the endeavour of the industries/government department to obtain the best-quality drugs on competitive basis.”

Second instance was, when the decision of the Government of Maharashtra regarding the international standards of medicine, was challenged (as mentioned above,) by a group of small-scale pharma companies in Bombay High Court. This time also, Justice Lodha not only approved the decision of the government, but mentioned that “health is wealth and public health is national wealth.” He also mentioned that asking for medicines of international standards is in public interest.

To put it succinctly, for the public health community, there is an urgent need for substantial and sustained efforts to engage with issues of trade, to strengthen institutional capacity in this area, and to push for health to be much higher on the agenda for trade negotiations. Coherence between trade and health policies at the country level is the key to effectively manage the interface between trade and health.

1. After death of 66 children in Gambia, WHO warns about four Indian cough syrups
2. publication reports on WHO–Situation of Medicines2007- 2012 and Access to MedicinesMay 2019
3. Report of the Expert Committee on a Comprehensive Examination of Drug Regulatory Issues, Including the Problem of Spurious Drugs (Chair: Dr. R. A. Mashelkar) submitted to Ministry of Health and Family Welfare, Government of India,New Delhi, November 2003
4. Smith RD et al Trade and health: an agenda for action Lancet. 2009 February 28;373(9665): 768–773.doi:10.1016/S0140-6736(08)61780-8.
5. Justice Lentin CommissionRecommendations Report afterinvestigation in the deaths of 14patients in Sir J. J. Hospital in1986
6. Judgment on Quality of medicines& WHO/GMP-2003-Bombay High Court at Nagpur(Writ petition No. 1702 of 2003in the high court judicature at
Bombay Nagpur bench

Dr Suresh SaravdekarGambia cough syrup deaths
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  • soundos

    Thank you so much for sharing your knowledge.