PXL/HO/Cir-007/2022-23                                                                            Date: 04.05.2022

Hyderabad

Dear Sir/Madam,

Subject: Alert by NAFDAC- Unprofessional Act of Indian Manufacturers/Exporters of

Pharmaceutical Products in Connivance with Nigerian Importers

Pharmexcil is in receipt of an alert from the NAFDAC stating that the manufacturers from India are following unethical and unprofessional practices with regards to product package design and drug formulation for Prescription Only Medicines exports.

The alert further states that it has become rampant as several prescription medicines manufactured in India and registered in Nigeria are being exported with outrageous unapproved pictorial representation and change in product formulations. It is also observed that it is done in connivance with Nigerian Importers leading to a situation where importers, exporters and manufacturers alter the approved product formulation, colour and package design in order to improve the pictorial appeal of prescription medicines to patients with the consequent problem of self-medication, drug abuse, public health risk and national security challenges.

In view of the serious manipulations, NAFDAC has notified the following decisions/directions to all manufacturers and exporters of India, for adherence and compliance:

1. All Manufacturers and exporters are to ensure strict compliance to NAFDAC registration guidelines, labelling and Good Manufacturing Practice Regulations as the products were registered. The guidelines and regulations are available on NAFDAC website:  https://www.nafdac.gov.ng

2. All Prescription only Medicines (PoM) and other categories of pharmaceutical products must strictly follow NAFDAC approved formulations and package designs.

3. A moratorium of six (6) months only has been approved for manufacturers to clear every consignment that violate the approved formulations and package designs. Note that clearance of such products is contingent upon processing and issuance of Clean Report of Inspection and Analysis (CRIA) issued by NAFDAC Approved CRIA Agents. This moratorium commences from 1st May 2022 and ends on 30th October 2022.

4. Any violative product that is boarded on airlines or shipping vessels from 1st November, 2022 will be confiscated upon arrival in Nigeria and any erring importer and manufacturer/exporter will be subjected to strict penalties, sanctions, product deregistration and consequent blacklisting.

5. All manufacturers/exporters who are in doubt of the approved formulation and package design presented to them by Nigeria Importers can contact NAFDAC via drugregistration@nafdac.gov.ng

Member companies are therefore requested to adhere to the directions of the NAFDAC for hassle free exports from India to Nigeria. Pharmexcil is also proposing to hold a VC to understand the guidelines framed by the NAFDAC and the same will be communicated.

With regards,

Uday Bhaskar
Director General