Comprehensive Permission Provisions From CDSCO To Overprint Imported Drugs
Drugs can be imported from foreign manufacturers into India for various purposes. They can be imported for free sale in the local market or for trials and promotions. Import of drugs in India is strictly regulated by the Drugs & Cosmetic Act of 1945 and the compliance of these regulations is overseen by CDSCO.
As already mentioned, different intentions for the import of drugs have their own specific requirements. Which may require the importer to overprint/stickering/stamping any extra information on the label.
The rule 104A of the Drugs and Cosmetics Act, 1945 grants an importer with permission to overprint the packaging of drugs. However, the application is specific to an intended purpose. For example, overprinting a drug for government use and physicians' use will require the importer to submit two different applications.
The problem with this is that the submission of two different applications is a tedious process and results in the wastage of time. It also creates extra workload on the licensing authorities, which is already crammed with a ton of applications.
However, in a recent change to these regulations. The authorities have decided to grant comprehensive permission of overprinting of all such products and not require individual applications to be made for different purposes. The overprinting refers to the addition of a “Not to be Sold” or any other label with relevant info to the existing labeling of the package.
The intended purposes and messages for overprinting in question here are:
● For hospitals/institutions/government supply - not to be sold
● For physician’s sample - not to be sold
● Manage access program/clinical trials use only/for post-trial access only, not to be sold
Moreover, the notification also mentions that such overprinting/stamping/stickering activity shall only be carried out at the licensed manufacturing/import premises without concealing the original label and with the consent of the local state licensing authority
Overprinting this information on packages becomes important in some cases. Since some drugs are only imported in the country for pre-marketing, sampling, or just clinical trials. The addition of such information makes it clear that the drug is not commercially available for sale and ensures the drug is only used where it should be.
Moreover, these labels also inform the user if one accidentally adopts such samples from somewhere.
This comprehensive approach towards overprinting is a commendable step and will ease the overall process of drug test license for importers.
