New Delhi (TIP)- Ever since Maiden Pharmaceuticals has come under the scanner of the World Health Organisation (WHO) after being flagged for the four cough syrups manufactured in India and exported to Gambia that led to the death of 66 children, it has come to light that the company has in the past flouted countless norms but was allowed to operate with impunity. While the statements from the Indian government state that the four cough syrups found to have dangerously high levels of ethylene glycol and deithylene glycol that led to kidney injuries were only licensed by the state drug controller for export and sale in Gambia, the company has been flagged in many Indian states over the years for their medicines failing the quality and safety parameters.

FRAUDULENT TRACK RECORD

Previous reports suggest that the company has been a serial offender on quality control standards in the past as many state governments, and authorities have flagged it. Dinesh thakur, a public health activist based in St Petersburg has published a long Tweet thread on the matter and has also raised questions over the functioning of the Central Drugs Standard Control Organisation (CDSCO) in India as well as the pre-qualification process of the WHO.

“Usually the CDSCO simply passes the buck in these cases to the state drug controller who issues the manufacturing licence. Except in this case Maiden Pharmaceuticals was certified by the CDSCO through the CoPP process. The national drug regulator, CDSCO provides assurance via the CoPP (Certificate of Pharmaceutical Product) to buyers overseas that it has inspected and ensured that the exporting pharma company complies with WHO cGMP standards. A pharma manufacturer has to provide this certificate (and the certification is not worth the paper it is written on) to the buyer overseas. Given the wonderful track record above of this company, does it not beg the question on what basis does the CDSCO issue this piece of paper,” Dinesh Thakur tweeted.

PREVIOUS MEDICAL RED FLAGS RAISED IN INDIA

In 2011, the government of Bihar also blacklisted Maiden Pharmaceuticals for supplying substandard drugs. A drug named Methylergometrine tablets which were provided to the civil surgeon in Munger was found to be spurious. Another batch of drugs, Erythromycin Sterate Syrup 125mg/5 ml was found to be of unsatisfactory quality. In states like Kerala, in 2017, a Judicial First-Class Magistrate Court in Kerala fined this company a small ransom of Rs 1,000 in a prosecution filed by a Drug Inspector in Kerala in 2005. EVEN Jammu and Kashmir has raised an alarm over substandard products. A central government drug inspector prosecuted the company in Sonipat, Haryana for quality violations under the Drugs & Cosmetics Act. The company was charged under sections of the drugs and cosmetics act, for offences related to adulteration.

According to the extended licensing, Laboratory and Legal Node (XLN) database maintained by the Government of India, at least two state governments Kerala and Gujarat have repeatedly warned of the company’s illegal practices. Several calls and messages to the company promoter Naresh Goyal, have gone unanswered.

COMPANY CLAIMS WHO-GOOD MANUFACTURING PRACTICES CERTIFICATE

The company website also says that it is a WHO-GMP (Good manufacturing practices) certified company that holds an international presence in many countries. “WHO-GMP Certified Formulations Company Manufacturers in India brings the best quality products.” The company carries more than 30 years of experience in the niche manufacturing of WHO-GMP Certified Formulations Company,” states the website. A WHO GMP holds credibility in the international market, and allows any company to enter into agreements with other countries for export as the company now has a WHO credibility tag on it.

                Source: India Today