Alleging manipulations by Indian drug manufacturers, the National Agency for Food and Drug Administration and Control (NAFDAC), Nigeria, has tightened norms for Indian drug manufacturers and exporters to Nigeria. The NAFDAC has sent an alert to the Pharmaceutical Exports Promotion Council (Pharmexcil), stating that manufacturers from India are following unethical and unprofessional practices with regards to product package design and drug formulation of prescription-only medicines.
The alert also states that malpractices have become rampant as several prescription medicines manufactured in India and registered in Nigeria were being exported with outrageous and unapproved pictorial representation and change in product formulations.
It was also observed that the unethical practices were being resorted to in connivance with Nigerian importers, leading to a situation where manufacturers, exporters and importers alter the approved product formulation, colour and package design to improve the pictorial appeal of prescription medicines to patients. This can lead to a consequent problem of self-medication, drug abuse, public health and national security challenges, said the alert.
As a result of alleged malpractices, the NAFDAC said a six-month moratorium has been approved for manufacturers to clear every consignment that violates the approved formulations and package designs. Clearance of such products is contingent upon processing and issue of a Clean Report of Inspection and Analysis (CRIA) issued by the Nigerian regulator-approved agents. The moratorium came into effect on May and will be in force till October 30.
Further, any violative product that is boarded on airlines or shipping vessels from November 1 will be confiscated upon arrival in Nigeria, and erring importers and manufacturers/exporters will be subjected to strict penalties, the alert warned.
In a communication to exporters and member companies, R Uday Bhaskar, Director-General, Pharmexcil, said the council plans to hold a video conference to facilitate understanding of Nigerian norms and guidelines, and also asked drug manufacturers and exporters to strictly adhere to the norms.
When contacted, an executive director with a Hyderabad-based pharma company, said: “The entire industry cannot be penalised even if there are some issues. We keep hearing these kinds of allegations whenever the brand value of Indian pharma flies high. I suggest the government of India to take up this matter seriously and investigate.’‘