Cough Syrup: ‘Recidivist’ Company Allowed to Export Substandard Drugs, Whistleblower Says | Exclusive

In an exclusive interview with India Today, public health campaigners Dinesh Thakur and T Prashant Reddy detailed the loopholes in drug regulatory mechanisms that allow substandard drugs to be licensed.

India Today spoke with Dinesh Thakur (right) and T Prashant Reddy (left) about drug regulatory mechanisms.

By Sneha Mordani: The World Health Organization (WHO) recently flagged cough syrups made by India’s Maiden Pharmaceuticals after 66 children died in The Gambia.

Dinesh Thakur, the whistleblower who exposed unsafe practices in the generic drug industry in 2013, co-wrote a book called “The Truth Pill” with public health activist T Prashant Reddy.

In an exclusive interview with India Today, Thakur and Reddy detailed what exactly are flawed in the drug regulatory mechanisms and what should be done to rectify the system and ensure that adulterated cough syrups do not reach any country.

Here are edited excerpts from the interview:

Q. What exactly is the ingredient in the cough syrup that caused these deaths in The Gambia?

The WHO press release states that the contaminants are diethylene glycol (DEG) and ethylene glycol. DEG is an antifreeze agent typically used in the manufacture of brake fluid, etc.

Q. What are the harmful side effects of ingredients commonly used in cough syrups for children that parents should be aware of?

DEG can cause kidney failure leading to death. It is almost always fatal in children.

Q. The office of the drug controller seems to suggest that the Haryana state regulator gave the approvals to this drug and the central body has nothing to do with the approvals. Is it possible? Isn’t it the central regulator that issues the certificates of CoPP – Certificate of Pharmaceutical Product?

Yes, you’re right. CoPPs are issued by CDSCO under the Ministry of Health. CDSCO took over this process in 2009 because state drug controllers were inconsistent in how they issued COPPs. The national drug regulator only issues the manufacturing license. If the central government. claims he has no role to play, that’s certainly not fair. The list of facilities certified for COPP published by CDSCO clearly has Maiden Pharmaceuticals on its list.

Q. The Indian government claims that these drugs were not licensed to be sold in India, but had the necessary clearances to be exported. What does it mean ? Can the Ministry of Health wash its hands like this?

Again, the government is deliberately obfuscating the issue. Once a manufacturing license is issued, the company can automatically sell in India. There is no regulatory process in Indian law that only allows export license without domestic manufacturing. Since Maiden Pharma was on the CDSCO COPP list, the Ministry of Health is responsible for these deaths in The Gambia.

Q. It seems that in India the law strictly punishes the falsification of medicines, it treats substandard medicines with leniency?

Yes that is correct. As we document in our book The Truth Pill: The Myth of Drug Regulation in India in several states like Maharashtra, Karnataka and Tamil Nadu, even when pharmaceutical companies are found guilty in court of manufacturing substandard drugs , the judges are very lenient towards them. They are usually sentenced to a simple term of imprisonment until the court rises, which means that they can leave as soon as the judge rises for the day. The accompanying fines are in the range of Rs. 5000 to Rs 1 lakh, which is loose change for most of these companies.

Q. The incident in The Gambia is not an isolated case, in 2019 when 12 children died in Jammu in India, questions were raised about the role of the regulator in authorizing these drugs, where stops the responsibility?

The main responsibility rests with the licensing authority which is the regulatory authority of the state in our current framework. But in the case of the present incident in The Gambia, since the DCGI issued a COPP, even the CDSCO bears the responsibility. How was he not aware of the company’s track record when certifying its products? On what basis does CDSCO issue a CoPP?

That said, there are plenty of blame points to be made, especially at the higher echelons of the Ministry of Health. The drug regulatory section of the Ministry is aware of these problems but has done little to remedy the situation. Ultimately, the responsibility should stop with the senior management of the department.

Q. Can drugs be exported to other developing countries without central regulator approval?

Yes, they can export unless the importing countries require a COPP, in which case CDSCO will need to issue a COPP.

Q. Maiden Pharma says they are WHO GMP compliant, so how is this certificate issued to a repeat offender?

Only the CDSCO can answer this question. The basis on which CDSCO issues these certificates is not made public.

Q. Toxic compounds, diethylene glycol and ethylene glycol have been used in this syrup, could there be other syrups as well where these are the key ingredients?

Yes definitely. DEG and EG were probably part of a batch of propylene glycol that was used to make drugs without testing. A public health response to this tragedy would require government. to urgently inspect Maidens facilities to verify how many products have been manufactured with propylene glycol or other industrial solvents and then to recall all such drugs from the market as Maiden Pharma may not have tested even the other batches. The government is playing with human lives by obfuscating the issue. The need of the hour is an immediate public health response to prevent the loss of more lives.

Q. Can you tell us about your upcoming book The Truth Pill: The Myth of Drug Regulation in India.

Our book is essentially a deep dive into the history of how India’s drug regulatory laws have evolved since pre-independence and how the law is actually enforced in the courts today. We use a variety of sources ranging from parliamentary debates to RTI responses to judgments of judicial magistrates to understand and explain how the pharmaceutical industry is barely regulated in India.

We hope the book will also provide an introduction for legislators. The most recent amendment proposed by the Department of Health and Family Welfare to the Drugs and Cosmetics Act this year creates more loopholes that industry can exploit, knowingly or unknowingly. If we are serious about preventing further incidents like the one in The Gambia or the deaths in Jammu in 2020, it is imperative that the government responds to the questions raised in our book.

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