Kala Amb drug firm ordered to stop production
Action follows spurious injection found in export consignment
In a decisive regulatory action, the state drug authorities have halted all production activities at Kala Amb-based M/s Welcure Remedies following serious and continuing deficiencies observed during a recent joint inspection conducted by the state and Central authorities.
Pertinently, a cardiac emergency injection produced by the firm was found to be spurious in an export consignment in June. A communication received from the Drugs Controller General of India (DCGI), based on a report of the Government Analyst at the Central Drugs Testing Laboratory, Mumbai, had declared a sample of adenosine injection, manufactured by the firm and bearing batch number WADG25002A, as spurious.
Officials said the injection, marketed through a Mumbai-based firm, was approved only for domestic distribution but was exported in violation of regulatory norms. The product was subsequently declared spurious in an African nation, bringing embarrassment to the pharmaceutical industry and raising concerns about regulatory compliance.
Taking serious note of the violation, the DCGI directed CDSCO officials in Baddi to conduct a detailed inspection in coordination with the state drug control administration. The first inspection, conducted in June, revealed deficiencies in manufacturing practices, prompting the authorities to first halt production and later revoke the firm’s licence.
The company was prohibited from manufacturing, selling or distributing any drugs under Section 18(c) of the Drugs and Cosmetics Act.
The company, however, went in appeal, following which the stop-production orders were revoked. Another round of joint inspection was conducted in August. Though the firm sought time to rectify the deficiencies, officials said, “A manufacturing facility can’t be permitted to rely upon assurances on product quality…” and termed its quality management system ineffective.
Lapses in microbiological testing and environmental monitoring, flagged in June, remained unaddressed. This prompted the Assistant Licensing Authority, Kala Amb, to issue fresh stop-production orders on September 8.
Health Secretary Ashish Singhmar said M/s Welcure Remedies, Kala Amb, had sought time to rectify the observations. However, keeping patient safety in consideration, the firm had been ordered not to commence production until satisfactory compliance was ensured and joint verification of its facility was undertaken by the regulators.
