Chandigarh : Prescription drugs used to treat type-2 diabetes and over-the-counter painkiller manufactured by Maiden Pharmaceuticals Ltd, a Delhi-based company having its manufacturing unit at Kundli in Sonepat district of Haryana, were found to be substandard during lab tests in Kerala on at least five occasions during the past nine months.
Maiden Pharmaceutical is under scanner after its four paediatric cough syrups were lab-tested and found to be of substandard quality by the World Health Organisation (WHO). As per WHO’s medical product alert, the four products are Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip N Cold Syrup. “The stated manufacturer of these products is Maiden Pharmaceuticals Limited (Haryana, India). To date, the stated manufacturer has not provided guarantees to WHO on the safety and quality of these products. Laboratory analysis of samples of each of the four products confirmed that they contain unacceptable amounts of diethylene glycol and ethylene glycol as contaminants,” the WHO said.
Samples that failed as early as June and Sept 2022
As per the Xtended Licensing and Laboratory Node (XLN) web portal of the central government, which has drug testing data, a sample of Metomin tablets containing Metformin (used for treating diabetes) from a primary health centre in Ernakulam in Kerala tested by a food and drugs laboratory (FDL) on September 28, 2022, were found to be of substandard quality. “The sample does not conform to Indian Pharmacopoeia (IP) 2018. This particular batch of sample fails the dissolution test. Hence declared not of standard quality,” reads the remarks on the XLN website. Phone calls made to Maiden Pharmaceutical’s Delhi offices did not elicit a response. Indian Pharmacopoeia is published on behalf of the Union health ministry and is recognised as an official book of standards for the drugs being manufactured or marketed in the country. It contains a collection of authoritative procedures of analysis and specifications of drugs for their purity, strength and identity. Its standards are authoritative in nature and enforced by regulatory authorities for ensuring the quality of drugs. The IP standards are legally acceptable during quality assurance and at the time of legal disputes.
Similarly, a sample of Easiprin tablets, a gastro-resistant Asprin drawn from Taluk headquarter hospital in Karimbam, Kannur in Kerala, were tested at the FDL, Thiruvananthapuram on June 30, 2022, and were declared not of standard quality as it did not comply with IP standards. The tablets manufactured at Maiden Pharma’s Sonepat facility were marketed by Kerala Medical Services Corporation.
A sample of Maical-D tablets drawn from Taluk hospital, Attingal, and tested at the FDL, Thiruvananthapuram on March 24, 2022, was also found to be “not of standard quality” having failed the content assay test, as per information on the XLN web portal of the central government.
Two more samples of Metformin tablets manufactured at Maiden’s Sonepat facility which were tested on March 19, 2022, and December 21, 2021, at FDL Thiruvananthapuram were found of substandard quality. The sample tested on March 19 was drawn from Taluk headquarter hospital, Pattambi in Kerala, and the one tested in December 2021 was drawn from a medical officer, primary health centre, Poruvazhy, Edakaddu city, Kollam. Both the samples, as per the XLN web portal failed the dissolution test and were declared not of standard quality.
Pharma company facing trial in Sonepat court
Maiden Pharmaceuticals along with its director, Naresh Goel and technical director, MK Sharma, is also facing trial in a Sonepat court. The matter is listed for October 28, 2022, for defence evidence before the court.
As per a court order of August 6, 2021, by special judge, Sonepat, Sanjeev Arya, a prima facie case under Section 27(d) of the Drugs and Cosmetic Act, 1940, was found to be made out. Accordingly, a charge-sheet for contravention of Section 18 (a) (i) read with Section 16 of the Act, punishable under Section 27(d) of the Drugs and Cosmetic Act, 1940, was issued on October 10, 2018, from the court of Ashwani Kumar, the then additional sessions judge, Sonepat.
The complainant in the case is a drugs inspector, Central Drugs Standard Control Organisation, North Zone, and the accused can be awarded a sentence to undergo imprisonment up to two years and pay a fine of ₹20,000 if convicted. Section 18 (a) (i) pertained to the prohibition of the manufacture and sale of certain drugs and cosmetics which is not of standard quality or is misbranded, adulterated or spurious.
Blacklisted by Bihar government
As per communication by the then executive director of State Health Society, Bihar, Sanjay Kumar, Maiden Pharmaceuticals was blacklisted by the Bihar health department for five years in 2011 after six batches of two drugs manufactured by it were found “not of standard quality” following lab tests and one batch of a drug was found to be spurious after being tested by central drug laboratory, Kolkata.
According to Maiden’s website, the company has got WHO-GMP and ISO 9001-2000 Certifications. “All products manufactured in our plants are equivalent to International Quality Standards & GMP norms are followed at each manufacturing step.Production is done under a highly controlled, fully air-conditioned in a hygienic environment,” it said.