Who is required to register on the IPDMS Ver 2.0?

Companies dealing in formulations and medical devices are required to register on the IPDMS 2.0. If a company deals in formulations as well as medical devices in that case that particular company needs to register separately for formulations and medical devices. Separate login credentials will be provided to such companies for handling formulations and medical devices segments.

What will happen with existing users after migration from IPDMS Ver 1? will the existing login credentials remain valid?

Existing Companies (registered under IPDMS Ver 1) dealing formulations only are not required to register afresh in the IPDMS 2.0 system, however medical devices segment companies are required to register afresh. Further, companies, dealing in formulations and medical devices, who are already registered had to register again for Medical devices segment and the existing credentials shall be useful for Formulations segment.

What data needs to be updated after the first login of existing companies?

Existing companies (Companies registered in IPDMS Ver 1 online system) after the first login must update/verify company’s details, company’s plants details and products being manufactured in their respective plants. To file Form I, II, III, IV, V and VI, such verification is mandatory.

What is the authentication process?

OTP will be sent to the company’s registered email address during registration process. The user will have to enter the OTP received on the registered email address in order to successfully register in the IPDMS 2.0 system. If any case of any difficulty, the same may be sent on nppa-ipdms@gov.in.

Will a company dealing in Medicines and Medical Devices have to register separately for Medicines and Medical Devices?

Yes, A company dealing in Medicines and Medical Devices will have to register separately for Medicines and Medical Devices.

What Are medical device companies required to be registered afresh?

Yes, the medical device companies required to register afresh in the IPDMS 2.0 system.

After first time login, how does a company submit IPDMS forms (I, II, III, IV, V and VI) or what are the pre-requisites for submitting IPDMS forms (I, II, III, IV, V and VI).

A company must add at least one manufacturing plant and the products being manufactured in that plant before filing any of the IPDMS form. Only those products will populate in IPDMS web forms (II, III, IV, V and VI) which have been entered by the company using product addition feature provided in the online system.

What information of a company can be updated by a company?

Company basic details as determined in the IPDMS 2.0 can be updated with the approval of NPPA only.

Can a company modify its products details?

Yes, but only with the approval of NPPA.