Kota Deaths: Pharmaceutical Distributor's Drug Licence Cancelled

Five women died between May 5 and May 17 at the JK Lone Hospital and the Super Speciality Wing of Government Medical College here following Caesarean sections, with health authorities examining whether the suspected fake oxytocin injections contributed to the deaths.

Assistant Drug Controller Devendra Garg on June 23 cancelled the firm Messer Rajasthan Medical Hall's wholesale licence after concluding that the distributor had committed multiple regulatory violations, officials said.

The order states that laboratory analysis of samples of Tosin-brand oxytocin injections supplied to hospitals found the oxytocin content to be nil, rendering the injections ineffective, they said.

The department also cited discrepancies in the firm's procurement and sales records.

The latest action follows an inspection carried out on May 19 at the distributor's premises in Indraprastha Industrial Area here.

Drug control officials reported finding suspected fake oxytocin injections along with several violations of the Drugs and Cosmetics Act and Rules.

The drug control department had also revoked the manufacturing licence of the Amritsar-based pharmaceutical company that produced the injections.

According to the investigation, the distributor had purchased 9,300 doses of the injections from the Amritsar-based M/s Jackson Laboratories but recorded sales of 10,050 doses. Officials said the unexplained difference of 750 injections raised questions about the source of the additional stock that allegedly entered the market.

The inspection further found that the firm's authorised representative, Shadab Khan, was absent during the visit, while proprietor Mahesh Mittal was allegedly handling the sale and distribution of medicines.

A show-cause notice was issued to the firm on May 21 seeking an explanation for the irregularities.

According to the licence cancellation order, the firm failed to provide a satisfactory explanation during the proceedings. The Assistant Drug Controller concluded that the violations, including the supply of substandard or spurious drugs and irregularities in record-keeping and distribution, warranted cancellation of the wholesale licence under the provisions of the Drugs and Cosmetics Act and Rules.

Officials said investigations are continuing to determine whether the alleged supply of fake oxytocin injections directly contributed to the deaths of the women and whether any regulatory lapses enabled the suspected spurious drugs to reach patients in government hospitals.

The probe is also focused on tracing the complete supply chain of the injections.

The Rajasthan's Drug Control Department had in late May banned the sale and use of TOCIN (oxytocin injection 5 ml), manufactured by Jackson Laboratories Pvt Ltd, after a sample of the drug failed in the quality tests.

The failed drug was one of the 20 drug samples collected from Govt New Medical College Hospital (NMCH) and JK Lon Hospital following deaths of pregnant women and infection among other women post Caesarean sections earlier this month. However, the remaining 19 drugs were found to be in compliance of the norms The drug department had also seized around 3,500 vials of the notified drug from Kota government hospitals and other stockists linked to the medicine's supply chain.

According to doctors, oxytocinis are routinely administered to induce labour and to prevent excessive bleeding after childbirth.