|
DCC calls for uniform system for quick action on spurious drugs, forms sub-committee for uniform SOPs
|
|
Gireesh Babu, New Delhi
November 28 , 2023
|
|
|
The Drugs Consultative Committee (DCC) of the Union health ministry has called for a uniform system in the country for quick actions in connection to the dissemination of information and suspension or cancelation of license for sale of spurious products, observing that the current system of drug alerts through the central drug regulator's website is not serving the purpose.
It has also decided to form a sub-committee to bring in a uniform Standard Operating Procedure (SOP) for administrative action taken by various State Licensing Authorities (SLAs) on critical, major and minor violations under the Drugs and Cosmetics Act and Rules.
In the 62nd meeting of the DCC, held recently, all states agreed to share the data related to the not-of-standard quality (NSQ) products and spurious products identified on monthly basis preferably before 10th of every month. This was following the deliberation that all SLAs should share the data to Central Drugs Standard Control Organisation (CDSCO) and it was opined to share a format with SLAs for submission of NSQ details to the Organisation.
"It is noticed that in the case of Spurious product the website alert having manufacturer name alone is not serving the purpose for awareness of stakeholder/ healthcare professional/patients to discontinue the identified Spurious product," said the Committee.
"There should be a robust uniform system in the country for quick actions like circulation of information on NSQ/spurious results including uploading on websites, suspension/cancellation of wholesale/retail license for sale of spurious product," it added.
It was observed that while isolated cases of spurious products of various companies are reported from various parts of the country, the wholesale and retail outlets are allowing circulation of these products for some extra profit and bypassing the authorised channel of distribution.
In general, sampling is carried by Drugs Inspectors of Central and State drugs control as per Section 22 & 23 of the Drugs & Cosmetics Act 1940 and Rules thereunder for routine drugs quality surveillance. The test reports are issued by state and Central government analysts. Every state has their own system/SOP for circulation/handling of NSQ results by various methods.
Test reports (Form-13) of NSQ/spurious/adulterated drugs received by CDSCO, HQ from Central Laboratories are uploaded as Drug Alert on the CDSCO website on a monthly basis as per Drugs Alert SOP.
As per the SOP, as and when the reports are received, the manufacturers as per the label of the product (as per Test Report) are requested to initiate product recall irrespective of proceeding by the Drugs Inspector. In some cases, the manufacturer reports to CDSCO that the products are not manufactured by them and the product declared as NSQ is purported to be spurious.
Subsequently, such cases are examined at CDSCO, HQ and accordingly depending on the details available Drug Alert is revised with remark, “The actual manufacturer (as per label claim) has informed that the impugned batch of the product has not been manufactured by them and that it is a spurious drug. The product is purported to be spurious, however, the same is subject to outcome of the investigation."
The DCC has also decided to form a sub-committee to examine a proposal for uniform implementation and action taken by the SLAs for violations of the provisions of the drugs as per the Drugs and Cosmetics Act and Rules.
CDSCO has received a representation regarding enforcement activities with respect to sale and distribution of drugs in one of the states. It stated that the concerned state is not having standard operating procedure for deciding violations of Act (critical, major and minor) and decisions are affected by the pressure from media, politics or administration and proposed timelines for suspension for first up to fifth time offenders are specified.
It was also stated that there was no uniform SOP for administrative action taken by various State Licensing Authority for (critical, major and minor) violations under Drugs and Cosmetics Act and Rules thereunder.
"The matter was deliberated in the DCC and it was decided to form a sub-committee having members from Madhya Pradesh, Maharashtra, one from CDSCO and two from consuming states to examine the matter and give its recommendations for preparation of an SOP. The sub-committee may also see the best practices followed by other states while preparing the SOP," it added.
|
|
|
|
|
|
|
|
TOPICS
|
That foods might provide therapeutic benefits is clearly not a new concept. ...
|
|
|
|
|