Manufacturing of Pharmaceutical drugs/ Medicines and Medical Devices Now Allowed in Same Premises 

Before: DRAP restricted utilization of approved premises for production of other relevant products due to which businesses couldn’t utilize extra space in manufacturing of allied products.

After: Now DRAP has allowed use of approved premises for additional relevant processes such as manufacturing medical devices

Medical Devices Manufacturers

Details

Difficulty

• Earlier, manufacturing of the medical devices was not permitted at the site where pharmaceutical drugs/medicines were being manufactured.
• This meant that approved premises for manufacturing  pharmaceutical drugs/medicines cannot be used to manufacture medical devices.
• This meant extra cost and procedural hassle for getting the new premises approved for manufacturing of medical devices, separately. Similarly, businesses were also unable to utilize the extra space at the plant site.

Analysis

• After consulting all the stakeholders and departments involved, it was agreed that businesses manufacturing the pharmaceutical drugs/ medicines may be allowed to manufacture medical devices at the same plot but in a different building.

Solution 

• To facilitate the businesses, the manufacturing of pharmaceutical drugs/medicines and medical devices is allowed in the same plot but in separate buildings after the requisite regulatory approvals.