‘Spurious’ injections that ‘contained no oxytocin’: Rajasthan pharma distributor loses licence
Authorities also alleged that the firm did not maintain a mandatory inspection register, and found that a qualified pharmacist was not present in its premises.
Rajasthan’s Drug Control Department has cancelled the wholesale drug licence of a pharma distributor operating out of Kota over the alleged sale of thousands of spurious oxytocin injections and other irregularities.
The action comes amid heightened scrutiny over the supply and use of oxytocin injections in Rajasthan, following the death of five women in Kota soon after giving birth.
According to an order issued by Drug Licensing Officer and Assistant Drug Controller Devendra Kumar Garg, officials on May 19 inspected the firm, M/s Rajasthan Medical Hall, located in the Indraprastha Industrial Area, and discovered alleged irregularities. The inspection team purportedly found that a mandatory inspection register was not being maintained and there was no qualified pharmacist at the site.
Authorities also alleged irregularities in the sale of injections that were supposed to contain oxytocin — generally administered to pregnant women during childbirth. It was alleged that the firm purchased 9,300 units of Tocin 1 ml injection manufactured by an Amritsar-based company, but sold 10,050 injections from the same batch. The Rajasthan Drug Testing Laboratory in Jaipur later declared the batch spurious after tests revealed that it contained no trace of oxytocin, its active ingredient.
A show-cause notice was issued to the licence-holder regarding the irregularities, and in response to the discrepancy in the number of Tocin 1 ml units purchased and sold, the firm produced a letter from the manufacturer claiming that 750 additional injections had been dispatched separately by bus. However, the Drug Control Department found the explanation unsatisfactory.
The department’s order stated that the firm violated rules 65(5), 65(6), and 65(16) of the Drugs and Cosmetics Rules, 1945, along with the conditions attached to its licences. Consequently, its wholesale drug licences and the Schedule X licence were cancelled with immediate effect.
Officials said the cancellation was independent of any judicial proceedings that are currently pending or may be initiated in the future.
Rajasthan’s Drug Control Department has cancelled the wholesale drug licence of a pharma distributor operating out of Kota over the alleged sale of thousands of spurious oxytocin injections and other irregularities.
The action comes amid heightened scrutiny over the supply and use of oxytocin injections in Rajasthan, following the death of five women in Kota soon after giving birth.
According to an order issued by Drug Licensing Officer and Assistant Drug Controller Devendra Kumar Garg, officials on May 19 inspected the firm, M/s Rajasthan Medical Hall, located in the Indraprastha Industrial Area, and discovered alleged irregularities. The inspection team purportedly found that a mandatory inspection register was not being maintained and there was no qualified pharmacist at the site.
Authorities also alleged irregularities in the sale of injections that were supposed to contain oxytocin — generally administered to pregnant women during childbirth. It was alleged that the firm purchased 9,300 units of Tocin 1 ml injection manufactured by an Amritsar-based company, but sold 10,050 injections from the same batch. The Rajasthan Drug Testing Laboratory in Jaipur later declared the batch spurious after tests revealed that it contained no trace of oxytocin, its active ingredient.
A show-cause notice was issued to the licence-holder regarding the irregularities, and in response to the discrepancy in the number of Tocin 1 ml units purchased and sold, the firm produced a letter from the manufacturer claiming that 750 additional injections had been dispatched separately by bus. However, the Drug Control Department found the explanation unsatisfactory.
The department’s order stated that the firm violated rules 65(5), 65(6), and 65(16) of the Drugs and Cosmetics Rules, 1945, along with the conditions attached to its licences. Consequently, its wholesale drug licences and the Schedule X licence were cancelled with immediate effect.
Officials said the cancellation was independent of any judicial proceedings that are currently pending or may be initiated in the future.