|
DRL gets final hearing from State FDA minister in a case related to violation of D&C Act
|
|
Shardul Nautiyal, Mumbai
February 27 , 2015
|
|
|
Following Maharashtra Food and Drug Administration (FDA) action against
DRL for supplying spurious products to doctors' clinics in violation of
Section 18 (a) (1) of Drugs and Cosmetics Act, the appellate authority,
the State FDA minister, has given a hearing recently to deliver judgment
for further action.
The State regulator had earlier taken
administrative action against the company by issuing an order to suspend
drug licences for violation of Rules 65 (5) (1) and 65 (5) (3) (ii) of
the Drugs and Cosmetics Act, 1940 for serious lapses in terms of
documentation and storage at company’s warehouse situated at Bhiwandi
near Thane.
The FDA assistant commissioner and licensing
authority G K Vakharia in his order released on November 19, 2014 had
suspended drug licences for the period January 12 to February 10, 2015
under Rules 66 (1) and 67 (H) of the Act. It was observed that the
samples of hand sanitiser were found to be not of standard quality.
Bombay
High Court had earlier granted an interim stay when the drug maker had
approached the court on the state government's suspension order on the
company's C&F agent after the state regulator found violations with
regard to some samples found in the warehouse of the company.
High
Court had granted an interim stay on the matter on January 8 for two
weeks and Dr Reddy's approached the State FDA minister on January 12
based on the court directive.
"In our opinion there has been no
violation of any statute or regulation by the company and it has been in
compliance. The order relates only to the wholesale licence of the
clearing and forwarding agent. The product being investigated is not a
drug and is neither manufactured nor marketed by us," a spokesperson of
Dr Reddy's had clarified.
The state FDA said the competent
authority's full signature was missing and the short signature found
during inspection of the Bhiwandi premises was not identical with the
original signature of the said authority. FDA had also found fault with
maintenance of stock transfer notes, saying they were not kept in the
chronological manner.
In its appeal to the state medical
education department Dr Reddy’s Laboratories stated, “If the licence is
suspended then irreparable loss will be caused because the company will
have to stock its drugs at other warehouses. Its various products would
not be made available to the stockists thereby resulting in shortage of
drugs to its consumers mainly patients suffering from various sickness
and diseases”.
The company officials further explained that the
products being distributed through medical representatives are
promotional items and not for sale. The documents verified were the
stock transfer notes that are accompanied along with the products when
products are being transferred from one location to another and they are
not classified as sale but mere transfer between the locations for
facilitating business operations.
|
|
|
|
|
|
|
|
TOPICS
|
That foods might provide therapeutic benefits is clearly not a new concept. ...
|
|
|
|
|