Nashik FDA to crack whip on pharma companies
The Food and Drug Administration (FDA),
Nashik has decided to go tough on pharmaceutical companies across the district
to ensure they follow all guidelines and not breach legal provisions of the
Drugs and Cosmetics Act, 1940.
The decision of the FDA comes on the backdrop
of a recent case where a pharmaceutical company was found not adhering to the
provisions under the Drugs and Cosmetics Act, after which it was issued a show
cause notice.
Senior officials said "In October, the
vigilance branch of the Maharashtra Food and Drugs Administration had got
information about some clandestine operations at the company located at
Musalgaon in Sinnar. The company is into manufacturing of tablets, capsules and
oral liquid for the past 15 years."
A team of drug inspectors inspected the
factory premises and found that the company had breached legal provisions of
the Drugs and Cosmetic Act. One of the official said, "The company manufactured
and distributed two batches of paracetamol and Ibuprofen suspension without
obtaining permission from the FDA. Apart from this the manufacturer also did
not kept any document regarding the said batch with respect to its
manufacturing, testing and distribution."
He added, "While the company was working in three shifts, a technically approved
person was available only for the general shift, while the second and third
shift was done in the absence of such person. Hence, a show cause notice was issued
to the firm."
Vijay Jadhav, Nashik FDA assistant commissioner,
while confirming the news, said, "While
FDA keeps a check on pharmaceutical companies on a regular basis, we will
intensify inspections across the division."
There are as many as 74 allopathic
pharmaceutical companies, 63 ayurveda pharmaceutical companies and 36 companies
of cosmetics in Nashik division that comes under the FDA.
Jadhav said goods manufacturing practices
cover all aspects of production from starting materials, premises, equipment,
training and personal hygiene of staff to maintaining records of products, test
of finished goods, among others.
Officials said last month a company based in
Ambad lost its licence. "During
inspection, we found that quality of medicine was not as per the standard.
Also, records of purchase of raw material and finished goods were incomplete,"
said an FDA official.
He added, "In view of the various non-compliances, the license of the
pharmaceutical company was cancelled by the FDA on October 14. The concerned
company, however, got a stay from the minister of food and drugs administration."
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