Chandigarh : The Haryana drug authorities have issued a show cause notice to Maiden Pharmaceuticals, which has its manufacturing unit in Sonepat, after deficiencies and inadequacies were discovered during a recent joint inspection by the Drug Controller General of India (DCGI) and Haryana drug regulator.
The joint inspection was conducted in the backdrop of World Health Organization (WHO) informing the DCGI that deaths of 66 children in Gambia were linked to the use of four cough syrups manufactured by Maiden Pharmaceutical and exported to the West African nation.
It is learnt that a show-cause notice has been issued to the pharmaceutical company under section 85 (2) of the Drugs and Cosmetics Rules which pertained to cancellation and suspension of license. Section 85 (2) empowers the licensing authority which is the state drug controller to cancel or suspend manufacturing and export licenses of medicines if the licensee has failed to comply with any of the conditions of the license or any provisions of the Drugs and Cosmetics Act or Rules.
The action is taken after issuing a show cause notice to the errant company to provide it with an opportunity to explain their side of the story. The licenses, as per section 85(2) can be cancelled or suspended completely or in respect of some of the substances it relates to. The state drug controller can also direct the licensee to stop the manufacture, sale or distribution of the said drugs and also order the destruction of drugs and the stock if the licensee has failed to comply with license conditions, provisions of the Act or Rules.
However, the nature of deficiencies detected during the joint inspection by DCGI and Haryana officials could not be ascertained.
The samples of the four cough syrups manufactured by Maiden Pharmaceutical and linked to the death of children in Gambia by the WHO are now with the Regional Drug Testing Lab (RDTL), Chandigarh and are likely to be moved to the Central Drug Laboratory (CDL), Kolkata. While the RDTL, Chandigarh is a statutory lab, the CDL, Kolkata is the national appellate laboratory and the only appellate authority in matters of disputes related to quality of drugs.
“Controlled samples of the same batch manufactured by Maiden Pharmaceuticals Limited for all the four drugs in question have been taken and sent for testing to Regional Drug Testing Lab, Chandigarh by central drugs standard control organisation (CDSCO), the results of which will guide further course of action as well as bring clarity on the inputs received from WHO,” said a Union health ministry statement.
As per preliminary enquiry by CDSCO, it was found that Maiden Pharmaceutical Limited is the manufacturer licensed by the state drug controller, Haryana for the four cough syrups lab tested by the WHO. They are Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip N Cold Syrup.
The company holds manufacturing permission for these products for export only and has manufactured and exported these products only to Gambia, union health ministry has said.
