After the Paschim Banga Pharmaceutical, the state health department directed yet another company Pharma Impex Laboratories in Baruipur of South 24-Parganas to stop production of all categories of medicines, including saline.
With health department’s directives to stop productions in the manufacturing units of the two major pharma companies that supply saline in most of the government hospitals and private healthcare facilities across West Bengal, there might be a huge crisis in supply of the life-saving IV fluids in the state.
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About a month ago, Paschim Banga Pharmaceuticals with directives of the state health department had stopped productions in its North Dinajpur unit after one new mother died and four others fell critically ill after giving birth to their babies at the Midnapore Medical College Hospital.
It is alleged that all the five mothers were given Ringer’s Lactate saline manufactured by the company during their caesarean deliveries.
On 29 January, the Directorate of Drugs Control (DDC), under the health department, issued an order directing the Pharma Impex Laboratories to stop production of all kinds of medicines at its Baruipur unit.
“An inspection carried out from 21-23 January by assistant drugs controller (I), CDSCO HQ, New Delhi and Inspectors of CDSCO HQ New Delhi and CDSCO (east zone) Kolkata along with inspectors of State Drugs Control Directorate of their manufacturing factory M/S Pharma Impex Laboratories Pvt Ltd of South Uttarbhag, Ramnagar, Baruipur, South 24-Parganas, West Bengal – 743387 for Risk Based Inspection.
It was appeared grossly deficient (Critical 05 & Major 26) in compliance with the current GMP standards (Schedule L1, Schedule-M) of the Drugs & Cosmetics Rules 1945,” the DDC order stated.
CDSCO stands for Central Drug Standard Control Organisation under the Union ministry of health while the GMP stands for good manufacturing practice.
“In exercise of power conferred upon the Deputy Director of Drugs Control, Government of West Bengal as licensing authority for the purpose of the part VII of the Drugs & Cosmetics Act and Rules, the firm is hereby ordered to stop the manufacturing activity of all categories of drugs manufactured under the license no. DL 2/SLA/CAA/WB dated 03.04.2017 at the site till the rectification of the reported deficiencies, as per Rule 85(2) of the Drugs Rules 1945 in the interest of the public service,” it stated.
A senior official of the state health department feared that there would be a huge crisis in supply of saline across West Bengal. Other states where two companies supply their products may also be affected.
The Mamata Banerjee government had engaged the company in Baruipur through a tender selection process to supply their saline to government hospitals in the state after it suspended productions in the Paschim Banga Pharmaceutical following the death of a new mother and critical illness of four others in Midnapore Medical College Hospital.
“Government hospitals in the state require more than 1.2 crore bottles of saline every year. The two companies manufacture more than 75 per cent of the annual requirements in public healthcare units besides private sector facilities,” an official of the central medical store (CMS), under the health department that procures saline.
