Maiden Pharma row: ‘Habitual offender’ firm cleared to export substandard drugs, claims whistleblower

Days after the World Health Organisation (WHO) red-flagged four products of Delhi-based Maiden Pharmaceuticals following the death of 66 children in The Gambia, two health experts have said that India's Ministry of Health is answerable for these deaths in the West African country.

In an exclusive interview with India Today, public health activists T Prashant Reddy and Dinesh Thakur said the primary responsibility lies with the licensing authority which is the state regulatory authority in our current framework.

But in the case of the present incident in The Gambia, they said, since the Drugs Controller General of India was issuing a COPP (Certificate of Pharmaceutical product), even the CDSCO (Central Drugs Standard Control Organisation) bears responsibility. "How was it not aware of the company's track record while certifying its products? What is the basis on which CDSCO issues a CoPP?" they asked.

The experts said there is plenty of blame to pass along, especially in the higher echelons of the Ministry of Health. "The drug regulation section of the ministry is aware of these problems but has done little to remedy the situation. The buck ultimately should stop with the top leadership of the Ministry," they said.

Thakur is the whistleblower who exposed dangerous practices in the generic drug industry in 2013. He has co-authored a book titled 'The Truth Pill' along with Prashant Reddy.

Maiden Pharmaceuticals, whose four syrups have been found to be of substandard quality, has a manufacturing plant in Haryana.  After the WHO's alert, the Centre appeared to wash its hands off by saying that the responsibility, in this case, was that of Haryana's health department.

The experts, however, said that the certificate of the pharmaceutical products (COPPs) is issued by the CDSCO which operates under the Ministry of Health. "The CDSCO took over this process in 2009 because state drug controllers were not being consistent in how they issue COPPs. The state drug regulator only issues the manufacturing licence," they said.

They further said that if the central government was claiming that it had no role to play, it was "most certainly not being honest". "The list of facilities certified for COPP published by the CDSCO clearly has Maiden Pharmaceuticals on its list," they said.

When asked about the Centre's position that these medicines were not given the license to be sold in India, the experts said that the government was deliberately obfuscating the issue as once a manufacturing licence is issued, the company can automatically sell products in the country.
"There is no regulatory process in Indian law that allows only for an export licence without domestic manufacture. Given that Maiden Pharma was on the CDSCOs COPP list the Ministry of Health is answerable for these deaths in the Gambia," they said.

Earlier, India Today reported that Maiden Pharmaceuticals is a habitual offender as it has defaulted many times and flouted rules before as well. The report said the pharma company has been flagged in many Indian states over the years for their medicines failing the quality and safety parameters.

The WHO on October 5 issued a health alert against Maiden's four products - Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup, and Magrip N Cold Syrup. The world health agency said that to date, Maiden Pharmaceuticals had not provided guarantees to the WHO on the safety and quality of these products.

"Laboratory analysis of samples of each of the four products confirms that they contain unacceptable amounts of diethylene glycol and ethylene glycol as contaminants. To date, these four products have been identified in The Gambia, but may have been distributed, through informal markets, to other countries or regions," the WHO said.

Speaking to India Today, Reddy and Thakur said that the government should inspect Maiden's facilities to check how many products were manufactured with propylene glycol or other industrial solvents and then recall all those drugs from the market because it is possible that the pharma company did not test 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 life," they said.