The high-level committee was constituted under the chairmanship of Prof SK Gupta, head of the Department of Neurosurgery. The Chandigarh health department was approached by a high-level committee of PGI doctors, earlier this week, to test Propofol, an anaesthetic, given to patients before surgery.
The reason was unexplained side effects of the drug during surgery and in the postoperative period and a few deaths at the institute. According to sources at PGI, these patients underwent surgery and were sedated with Propofal, and the untoward reaction initiated this step of testing the drug.
In view of the suspected adverse drug reactions of the drug Propoven (Inj. Propofol IP 10 mg/ml) manufactured by Becure (Biovenic Criticure), the PGI administration has now issued a show cause notice to M/s Gupta Medicos, a chemist shop at Emergency Block, PGI, from where the drug has been reported to be procured by the patients and attendants.
The high-level committee was constituted under the chairmanship of Prof SK Gupta, head of the Department of Neurosurgery.
The Drug Controller, Chandigarh, and Central Drugs Standard Control Organisation (CDSCO), Baddi, have also been duly informed to examine and fact-find the case and their reports are awaited.
The show cause notice has been served to M/s Gupta Medicos as per the terms and conditions of licence deed, which mandated ensuring the sale of quality products, medicines, drugs, etc., and in no case, the items which are spurious, or soiled would be stocked or sold. Breach of these conditions entails the cancellation of the license.
The products are required to conform to the rules and laws of the government regarding their sale.
As per the show cause notice issued, Gupta Medicos has been directed to explain its position within a week from the date of issue of the notice, regarding the sale of the said drug and as to why action may
not be taken against them as per the terms and conditions of the licence deed.