Unprofessional Indian companies get a significant relief.

Indian drug manufacturers and exporters accused of being engaged in unprofessional acts in connivance with Nigerian importers got a significant relief when the National Agency for Food and Drug Administration and Control (NAFDAC) of Nigeria granted them a moratorium of six months to clear all the consignments that violate their approved formulations and package designs.

Clearance of such pharma products is contingent upon processing by National Agency for Food and Drug Administration and Control (NAFDAC) of Nigeria and issuance of a Clean Report of Inspection and Analysis (CRIA) issued by Clean Report of Inspection and Analysis agents approved by the National Agency for Food and Drug Administration and Control (NAFDAC) of Nigeria. This moratorium granted by the National Agency for Food and Drug Administration and Control (NAFDAC) of Nigeria to Indian importers will commence on May 1, 2022, and end on October 30, 2022.

Several prescription drugs manufactured in India and registered in Nigeria are thus being exported with an outrageous and unapproved visual representation and change in product formulations. These unprofessional activities are being done in connivance with Nigerian importers leading to an industry circumstance where importers, exporters, and manufacturers are altering the approved product formulations, colors, and packages designed to improve the visual appeal of prescription medicines to patients. Such appeals can lead to the consequent problems of self-medication, public health risk, drug abuse, and national security challenges, claimed the National Agency for Food and Drug Administration and Control (NAFDAC) of Nigeria in a statement.

The National drug regulator of Nigeria National Agency for Food and Drug Administration and Control (NAFDAC), has recently communicated to the Pharmaceuticals Export Promotion Council of India (Pharmexcil), writing that the manufacturers from India were involved in these unethical and unprofessional practices with regards to product package design and drug formulation for prescription medicines exports.

Upset with malpractices by Indian drug makers and exporters, the National Agency for Food and Drug Administration and Control (NAFDAC) of Nigeria has asked them to ensure strict compliance to the registration guidelines for labeling and manufacturing practice regulations as the drugs were registered. “All prescription-only medicines (PoM) and other categories of pharmaceutical products must strictly follow NAFDAC approved formulations and package designs,” it commanded.

National Agency for Food and Drug Administration and Control (NAFDAC) of Nigeria further claimed that all manufacturers and exporters who have doubts regarding the approved formulation and package design provided to them by Nigeria importers could reach out to it.

Any violative product boarded on airlines or shipping vessels from November 1, 2022, is to be confiscated upon arrival in Nigeria. Any erring importer and manufacturer. Exporters will be subjected to strict penalties, sanctions, product deregistration, and consequent blacklisting, said Nigeria’s National Agency for Food and Drug Administration and Control (NAFDAC).

Pharmexcil of India has requested member companies to adhere to the directions of the National Agency for Food and Drug Administration and Control (NAFDAC) of Nigeria for hassle-free exports from India to Nigeria.

The Council is also proposing to hold a virtual online conference to understand the guidelines framed by the National Agency for Food and Drug Administration and Control (NAFDAC) of Nigeria, and it will communicate the same.

India’s exports of pharmaceutical products to the African country were US$ 564.92 million in 2021. Nigeria is currently one of the top five pharma export destinations in India, and the other four include the United States, United Kingdom, South Africa, and Russia.

Nigeria is currently facing a massive problem of imported substandard drugs. The African country is heavily dependent on drug imports, and it imports at least 70 percent of its current drug requirements. India is currently one of the biggest exporters of pharmaceutical drugs to Nigeria. That is not the first time the Nigerian government has raised a red flag against Indian pharma companies. In October 2020, the National Agency for Food and Drug Administration and Control (NAFDAC) of Nigeria blacklisted Gujarat-based Mars Remedies for exporting substandard antibiotic ciprofloxacin, accusing them of lacking transparency and quality.