The Directorate General of Health Services (DGHS), the medical stores organisation of the Union Ministry of Health and Family Welfare, has recently blacklisted or debarred some of the products from four out of the five pharma manufacturing public service undertakings (PSUs) in the country for failing to meet quality standards.
According to an announcement by the ministry, some of the products from the Indian Drugs and Pharmaceuticals Ltd (IDPL), Bengal Chemical and Pharmaceuticals Ltd (BCPL), Rajasthan Drugs and Pharmaceuticals Ltd (RDPL) and Karnataka Antibiotics and Pharmaceuticals Ltd (KAPL) have been de-registered by the DGHS retracting them from further supplies to government drug purchase.
The companies are de-registered permanently from supply lists from January 2009. The action is against ranitidine 150 mg tablets and nofloxacine 400 mg tablets of BCPL, ORS powder and metronidazole 400 mg tablets of RDPL and diclofenac sodium 50 mg tablet and dexamethasone sodium phosphate 4 mg/ml injection of KAPL even as the IDPL has been just blacklisted without mentioning defect in a particular product.
At least two out of these four companies have denied any fault from their part for the action and are planning to move court for redressal, it is learnt. Sources from RDPL revealed that the action was taken without paying heed to the explanation of the company and the products were found faulty in only one of the labs even as the drug should be tested in two government owned drug testing labs according to rules and regulations.
A higher official from RDPL said that the ORS solution tested in the Central Drug Laboratory (CDL), Kolkata was already in a damage condition due to heavy moisture in West Bengal in July 2008. The product was not in a condition for supply while the DGHS tested even as the rest of the stocks with the company were found of standard quality when tested by the Rajasthan drug regulators. Though the formal samples of metranidazole tablets were passed the tests by CDL, the DGHS has conducted informal tests and disqualified the product pointing out that the product failed dissolution tests, said the official.
RDPL and IDPL are planning to contest the decision of DGHS in the court, said sources from both the companies. The officials said that the deputy additional director general (DADG) with the DGHS was taking a totally unilateral stand against the PSUs. While the RDPL sources said that the DADG was not responding to the correspondences of the company, the IDPL sources said that the company is going to resolve the issue either through correspondence with the DGHS or by filing a case against the directorate.