CDSCO urges Pharma Companies for urgent release of stocks after Relabeling

There has been a reported shortage of essential medicines after implementation of GST on 1st July 2017. Responding to the news, Central Drugs Standard Control Organization (CDSCO), Directorate of General of Health Services, Ministry of Health and Family Welfare has informed drug makers and state regulators to ensure that essential medicines are available to patients across the country through a recent notice.

In a recent notice, CDSCO states there are reports in press that essential medicines for treatment of Diabetes and other diseases are in short supply following implementation of GST across India. This is due to fear of possible financial loss because of implementation of GST that the drug companies are not releasing their finished products into the market although stocks of hundreds of crores are kept in godowns.

on the representation of Industry Associations like FICCI, IDMA, IPA and others regarding allowing alteration of labels (stickering) due to implementation of GST,CDSCO announced proactive measures and issued a Notice dated 10.07.2017 clearly stating that it has no objection for alteration of label (stickering) by the manufacturers under rule 104A of the Drugs and Cosmetics Rules, 1945, if required, for effective implementation of GST subject to provisions of Legal Metrology Act & Rules and other provisions of Act and Rules relating to Goods & Service Tax.

The said Notice has been issued to facilitate the manufacturers for switching over to the new regime of GST smoothly so that medicines could be made available to the patients without any regulatory hurdles.

CDSCO has requested the drug makers and state regulators to take appropriate measures to ensure availability of essential medicines in respective territories and has assured all the assistance required in the matter.

Below is the attachment for the same.