The Wire Staff 
New Delhi: The director and technical director of Maiden Pharmaceuticals have been found guilty by a local Sonepat court in a case of substandard medicine, Rantitidine 150 mg (Mantek-150 Tablets). The court has sentenced them to rigorous imprisonment for two-and-half years and have been asked to pay a fine of Rs 1 lakh each.
Sanjeev Arya, additional sessions judge, pronounced the judgment on Wednesday, February 22. However, the sentences awarded to the director, Naresh Kumar Goel, and technical director, M.K. Sharma have been suspended so that they could appeal against the quantum of the sentence in a higher court till the stipulated time period which ends on March 23.
It may be mentioned here that Maiden Pharmaceuticals was embroiled in controversy as the World Health Organisation issued a product alert in October last year linking the deaths of 70 children in Gambia with cough syrups made by the company.
The Wire reported in December that their formulations contained two contaminants in huge quantities. However, the government of India, in its own investigation cleared the name of the firm and said it found no contaminants in those products. The WHO, nonetheless, refused to accept this finding of the Indian government and the alert is still valid. A parliamentary report of Gambia had concluded that Maiden Pharmaceuticals was ‘culpable’ for the deaths.
Ranitidine case
Deepak Mittal, the Indian consul general at Ho Chin Minh City in Vietnam, had written to India’s health ministry on December 23, 2013, stating that the east-Asian country had blacklisted 46 Indian companies for supplying substandard drugs. Maiden Pharmaceuticals was one of those companies.
“In view of the fact that a large number of Indian companies have been listed as defaulters by the Vietnamese authorities, it is requested that necessary background checks on these companies may kindly be undertaken in India to see if there are complaints against them from other countries and steps be initiated to penalise them for bringing bad name to the Indian pharma industries abroad,” Mittal’s letter had said.
As a follow-up to this complaint, drug inspector Dinesh Kumar and Drug control officer Parveen Kumar Food and Drug Administration visited the plant of the company in March 2014. The officials collected samples of ranitidine from the finished goods store of the company. They sent those samples for analysis to Regional Drug Testing Laboratory, Chandigarh. The government lab declared the samples as ‘Not of Standard Quality’ (NSQ).
The lab said the samples failed to conform to the claims made by British Pharmacopoeia (BP 2013) in terms of “uniformity of weight and assay”. In other words, the lab found that the samples did not have uniformity of active ingredients of the drug. The drug officials issued a notice to the company asking it to stop the sale and distribution of the said drugs and withdraw the stock from the market immediately on September 1, 2014.
The company replied to the officials that it had not sold the said batch of 61,000 tablets to any customer as an “internal Quality Control department” had also found them to be not of standard quality.
Now, clause 2.6 of Drugs and Cosmetics Rules,1945, mandates that a separate, segregated place should be provided for the storage of ‘rejected materials’. Those drugs are not supposed to be kept along with finished drugs meant for sale.
The clause states: “Segregation shall be provided for the storage of rejected, recalled or returned materials or products. Such areas, materials or products shall be suitably marked and secured. Access to these areas and materials shall be restricted.”
In the reply to the inspector, the company accepted that it had kept the 61,000 tablets of ranitidine, found not of standard quality, with finished products but as “Finish Goods rejected stock”.
The judge found this an admission of guilt. “The aforesaid reply makes it ample clear that 61000 Tablets of Ranitidine Tablets BP {Mantek-150} were not of standard quality, even then, accused No.2 & 3 [directors of company] did not adhere to comply Clause 2.6 of Drugs and Cosmetics rule, 1945…”
And, this according to the judge, was done with the specific purpose of sale of substandard drugs.
The judgment reads: “Keeping in view sub-standard quality drugs in Finish Goods Store would make it clear that sub-standard quality medicines were kept for the purpose of its sale due to deriving undue gain and such type of sub-standard quality drugs were also exported, as a consequence, respondent / accused No.1 i.e. M/s Maiden Pharmaceuticals Ltd. having its Directors, i.e. respondents No.2 and 3, was black listed [sic].”
The directors were held guilty under Section 27(d) of the Drugs and Cosmetic Act, 1940 and awarded imprisonment, which, though stands suspended for a time period.