The country’s deficient drug regulation system has come under scrutiny again after 69 children in Gambia died after consuming cough syrups manufactured by a Haryana-based pharmaceutical company. It is not the first time that bad recordkeeping along with the passing of substandard medicines without proper quality checks has raised health concerns for people.
India is the third largest country in the world in terms of producing medicine in the highest quantity. Yet spurious and counterfeit medicines are flowing into the market freely. It is obvious that pharmaceutical firms are accustomed to exploiting lax quality testing regulations, subpar supply and procurement systems, a disjointed system of licensing authorities, and gaps in the implementation of drug regulatory statutes.
In recent decades, adulterated and falsified drugs have still received a lot of media attention and caused some public debates. However, substandard drugs being produced on a large level, which also lead to deaths, have not been able to make it to major news.
It’s not the first time drugs have failed quality tests and led to the loss of life in India. Between December 2019 and January 2020, cough syrup “poisoned with diethylene glycol” was linked to the deaths of 14 infants in Udhampur’s Ramnagar and Jammu’s Bishnah districts. A CDSCO assessment conducted between 2014 and 2016 found that 5 percent of Indian medications, many of which were produced by major pharmaceutical corporations, failed the quality test.
In Himachal Pradesh, quality control tests on roughly six samples of medications failed in June 2020. There was also an earlier incident in 2016, when the drug enforcement agencies of seven states claimed that 27 medications sold by significant Indian pharmaceutical businesses were of inferior quality.
The manufacturing and sale of low quality drugs comes along with a whole lot of other consequences than just reported deaths. Continuous consumption of substandard medicines has proven to lead to a reduction in the effectiveness of a medication for treating diseases. Apart from that, in several cases, patients have also suffered adverse effects from unexpected ingredients. Falsified medicines not only threaten the health of populations today but also in the future. This also comes with an economic burden on the people. Poor quality drugs often lead to additional health treatment costs that most people can’t afford. Moreover, the trust of the people is ultimately diminished by both the manufacturing companies and the government.
Approval for the marketing of drugs and medical devices in the country is governed by the Drugs and Cosmetics Act, 1940. Several times, complaints have been made about the inadequate rules that were written to implement the statute. Although the substandard production of drugs and devices can be prosecuted under the law, most of the time the offenders go free due to poor surveillance. Even if a drug is supposedly banned in one state, it can be easily sold and consumed in another due to a lack of a national level binding mechanism. Due to the presence of multiple regulators there are always problems of coordination and single enforcement.
In addition to this, neither the inspectors nor the SDRAs (State Drug Regulatory Authorities) are required to maintain a record of non-compliant and offending drug manufacturers. This has repeatedly caused issues with tracking and prosecuting repetitive offenders. There have been multiple cases of approval of drugs without adequate evidence and abuse of the approval process by both the manufacturers and the regulators. In addition to this, India has also seen cases when trial reports have either been manipulated or completely covered up in cases of unfavourable results. Miscommunication, understaffing, and ill-equipped inspectors have added to the problem.
Weak Indian drug laws are costing the lives of people around the globe. The state of affairs is not only sad but concerning. The recent Gambia incident is a wake-up call for us to strengthen our drug regulatory framework. There is a need for newer mechanisms and structures to be in place. The new drug regulatory framework should be based on the ideas of transparency, effectiveness, and in-accordance with international set standards and contemporary public needs.
The quality test results have to be made more transparent and should be without notice checked by regulators on a frequent basis. Banning a manufacturer from one region should also prevent them from bidding with other organisations in different regions. Additionally, government authorities have to be manforced with people who are better equipped to ensure quality checks from manufacturing to procurement to sales.
It is time we started cleaning up the mess in the pharma industry before another such incident takes place.
Mahek Nankani is Assistant Programme Manager, The Takshashila Institution. Priyal Lyncia D’Almeida is a Research Analyst at Takshashila. Views expressed are personal.
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