Spurious Drug Menace

[vc_section][vc_row][vc_column width=\”1/2\”][vc_column_text css=\”.vc_custom_1672057763880{border-top-width: 1px !important;border-right-width: 1px !important;border-bottom-width: 1px !important;border-left-width: 1px !important;padding-top: 20px !important;padding-right: 20px !important;padding-bottom: 20px !important;padding-left: 20px !important;background-color: #434a9b !important;border-left-color: #434a9b !important;border-left-style: solid !important;border-right-color: #434a9b !important;border-right-style: solid !important;border-top-color: #434a9b !important;border-top-style: solid !important;border-bottom-color: #434a9b !important;border-bottom-style: solid !important;}\”]1. Experts in the Panel

• Raman Gangakhedkar, Dr. C.G. Pandit National Chair, ICMR
• Sanjay Singh, Director & CEO, Gennova Biopharmaceuticals Ltd
• M.C. Mishra, Former Director, AIIMS, New Delhi

[/vc_column_text][vc_column_text]2. Reasons for being in News

The death of 66 children in Gambia, linked to cough syrups manufactured by an Indian firm, has spurred the government to launch an urgent probe into the matter. Samples of the cough syrups, being blamed for the deaths, have been sent for testing. This after the World Health Organisation raised an alert, linking the deaths in Gambia to the four cough syrups, made by Haryana-based Maiden Pharmaceuticals. The global health body says as per the initial lab analysis, each of the four cough syrups contained unacceptable amounts of diethylene glycol and ethylene glycol, considered to be poisonous compounds. Although the exact one-to-one causal relation of death has not been provided by the UN health agency. India has sought the report on the establishment of a causal relation to the deaths with the medical products in question, photographs of labels/products etc. which will help in further investigation and action. While the probe is on, the incident has certainly put the spotlight once again on quality monitoring and due diligence by companies and the need for stricter regulations.

3. Discussion

3.1. Introduction

The death of 66 children in the Gambia, linked to cough syrups manufactured by an Indian firm, has spurred the government to launch an urgent probe into the matter. Samples of the cough syrups, being blamed for the deaths, have been sent for testing.

The global health body, World Health Organisation (WHO) raised an alert, linking the deaths in the Gambia to the four cough syrups, made by Haryana-based Maiden Pharmaceuticals.  WHO says that as per the initial lab analysis, each of the four cough syrups contained unacceptable amounts of diethylene glycol and ethylene glycol, considered to be poisonous compounds.

Although the exact one-to-one causal relation of death has not been provided by the UN health agency, India has sought the report on the establishment of a causal relation to the deaths with the medical products in question, photographs of labels, products, etc. which will help in further investigation and action.  While the probe is on, the incident has undoubtedly put the spotlight once again on quality monitoring and due diligence by companies and the need for stricter regulations.

3.2. Why did this happen?

India is known as the ‘pharmacy of the world’ and this incident has dented India’s image both nationally and globally. Both the compounds diethylene glycol and ethylene glycol are not the usual constituent of cough syrup. They are toxic and often used in paint industries.

One possible explanation for the presence of these compounds can be attributed to Glycerine which is used in the manufacture of cough syrup as a sweetener. The glycerine might have been contaminated with these compounds. The presence of diethylene glycol has caused several fatal incidents even in India, where innocent lives have been lost.

A detailed investigation considering multiple aspects like the cause of sickness of the children, the quantity consumed by them, and whether they were suffering from any other disease needs to be done. Moreover, the Government of India instead of being defensive should collaborate with the Gambian government to look at the matter in depth. A detailed investigation should be carried out at all levels.

3.3. Issues that might exist

Since the investigation is underway, the cause of the incident cannot be found but the possibility exists that there have been certain lapses in the quality check. There might have been a failure on the part of the company as well.

The possibility of the spurious drug being used for malafide intentions can also be considered. But these are mere speculations. The data on effective inspection of the sites every three years is usually missing. The response of the Gambia to the issue was very slow, it took 66 deaths to analyze the root cause of the menace.

It is also important to understand that less developed countries like the Gambia lack an effective regulatory mechanism. It should also be noted that the alleged manufacturer, that is, Maiden Pharmaceuticals, has been banned by several states (like Bihar and Kerala) in India as well. The company has also faced controversies in the past. The matter of the continuation of the company even after such incidents needs to be deeply analyzed. The source of the issue can also be the raw materials which are majorly imported from countries like China.

3.3.1. Other specific issues

• DCGI does not have adequate manpower for carrying out the inspections and audits.
• It is often argued that the regulatory process has not kept pace with the expansion of the pharmaceutical industry in the last two decades.
• Shortcomings have also been cited in terms of infrastructure and quality standards.
  

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WHO and Indian regulator at logger-heads

The WHO had issued a product alert against the said products on October 5, 2022. The Indian drug regulator, Central Standards Drug Control Organisation, however, said in a letter to the WHO on December 13 that its own investigation of control samples of these syrups did not reveal any contamination and accused the WHO of premature deductions (For every batch of the drug which is released in the market, a manufacturer is supposed to preserve samples, known as ‘control samples’, for any future investigation). The CDSCO, nonetheless, has neither made its report public nor has it revealed any details of its own investigation.

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3.4. System of Checks and Balances in the Pharmaceutical Industry

In the industry, raw materials have to qualify for certain parameters. All these parameters are further cross-checked when the final product is ready. Based on its result the product is released in the market. A check and balance system also exists in the pharmaceutical industry as it is closely connected to human life and thus has to be efficiently maintained. Standard parameters, formulation, and testing procedures are also clearly defined.

When a generic drug is introduced, for the first four years and up to five countries can approach the Drug Controller General of India (DCGI). After rigorous clinical trials, the drug is approved. Once four years have passed, the state Food and Drug Administration (FDA) unit can give permission to manufacture, market, and provide licences. The quality checks, rules, and regulations are by and large the same for the products that are domestically consumed and the products that are exported.

3.5. India’s Responsibility and Implications of the Incident

The pharmaceutical industry is a sunshine sector in India and India is known as the ‘Pharmacy of the World’. India has the responsibility to produce drugs that are safe, efficacious, and affordable.

India supplies drugs to both least-developed countries and highly regulated markets. In the past, several companies have acted responsibly by recalling the drugs in case of any minor or major complications. The incident has created a dent in the image of India at an international level and affected its credibility.

3.6. Future Course of Action

The investigation needs to be done at a bullet speed and results have to be published to find the cause of concern. State FDA should be empowered, especially after this particular episode.

It is also important to train less developed countries for regulation before accepting any drug. The Government of India being a responsible country apart from being the pharmacy capital of the world can collaborate with WHO in this direction. India should strengthen its regulatory capacity and capability. There should be strict actions against the involved stakeholders, to send a strong deterrent message across the entire sector.

Good Manufacturing Practices need to be in place with serious action in case of violation. All the stakeholders should act responsibly. The industry should be responsible for quality products.  The government can also establish accredited agencies to conduct regular audits, because of the lack of manpower in DCGI and state FDAs. Highly qualified personnel needs to be employed and should be periodically trained.

3.7. Conclusion

India over the years has built the credibility of providing medicines to almost 200 countries on the basis of trust and that credibility needs to be maintained. The pharmaceutical industry holds moral responsibility as it involves the matter of life and death. The industry should look beyond profit and loss business and should ensure that the trust of common people continues.[/vc_column_text][/vc_column][vc_column width=\”1/2\” is_sticky=\”yes\” sticky_min_width=\”767\” sticky_top=\”130\” sticky_bottom=\”0\”][vc_custom_heading text=\”Perspective: Spurious Drug Menace | 07 October, 2022\” font_container=\”tag:h2|font_size:24PX|text_align:center|color:%23ffffff|line_height:34PX\” use_theme_fonts=\”yes\” css=\”.vc_custom_1672061029146{margin-top: 0px !important;margin-bottom: 0px !important;padding-top: 10px !important;padding-right: 10px !important;padding-bottom: 10px !important;padding-left: 10px !important;background-color: #434a9b !important;}\”][vc_video link=\”https://youtu.be/cZqJVuIoHmM\” css=\”.vc_custom_1672061012111{margin-top: 0px !important;padding-top: 0px !important;}\”][/vc_column][/vc_row][/vc_section]