Drug Dept asks Pharma distributors to ensure vendor validation: AP

The State Drugs Control Administration has asked distributors in the State to obtain the required data and keep it ready by March 15, 2021.

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FDA

Last Updated on March 6, 2021 by The Health Master

To bring transparency, accountability and ensuring due diligence by pharma distributors in Andhra Pradesh, the State Drugs Control Administration (AP DCA) has asked drug licensees to adhere to the principles of vendor validation and self-compliance measurements.

The State Drugs Control Administration has asked distributors in the State to obtain the required data and keep it ready by March 15, 2021.

The authority informed that the objective of reiterating the statutory obligation is to prevent the entry of spurious drugs or cosmetics products manufactured outside the state, which are being marketed / traded / sold in the state by unscrupulous elements.

With such measures, it will ensure the investigation to trace the responsible persons/firm, upon detection of such spurious drugs / cosmetics, since at times it is taking more than expected time for want of requisite details from the persons / firm from whom such spurious drug is found / seized.


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S Ravi Shankar Narayan, IRS, Director General, Drugs and Copyright, Drugs Control Administration, Andhra Pradesh, informed, “In some of the instances, we were unable to trace and track the provided information by the distributors in time, which lead to delaying the whole process of investigation. Therefore, we have reiterated the statutory obligation of the dealers in exercising due diligence.”

The issued circular by the Director-General, Drugs and Copyright, Drugs Control Administration, stated that:

Medical Store Pharmacy
Picture: Pixabay

As a part of due diligence all the licensee retailers, wholesalers, distributors, stockists, etc, of drugs and cosmetics who are neither manufacturers nor their agents and purchasing / procuring/obtaining drugs and cosmetics directly from retailers / dealers / distributors / wholesalers / stockists / agents / manufacturers, etc. located outside the state of Andhra Pradesh henceforth need to obtain and possess the following information pertaining to such parties located outside the State of Andhra Pradesh in respect of the drugs and cosmetics being dealt by them and produce the same to the Officers of Drugs Control Administration during inspections conducted as per law. 

1.Name, address and other particulars of the manufacturer(s) and out of state dealer / distributor / wholesaler

2.Copy of the drugs license of the manufacturer(s)and out of state dealer / distributor / wholesaler.

3.Copy of approved product list of the Manufacturer(s) containing the products being dealt by the firm.

4.Constitution particulars of the manufacturing firms(s) and out of state dealer / distributor / wholesaler along with Name, Address and Contact details of the person(s) responsible for day-to-day affairs of the firm for the manufacture and sale of drugs.

The circular continued, “In respect of the stocks on hand as on date, including those in transit and falling in the above-mentioned category of purchases, the details as specified above may be obtained and kept on record by March 15, 2021.”


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Record keeping for Medical Store / Pharmacy

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