Last Updated on December 31, 2023 by The Health Master
Drugs to Nigeria
Drugs to Nigeria: In a big relief for Indian drug manufacturers and exporters engaged in unprofessional acts in connivance with Nigerian importers, the National Agency for Food and Drug Administration and Control (NAFDAC) in Nigeria has granted them a moratorium to clear every consignment that violates the approved formulations and package designs.
Clearance of such products is contingent upon processing and issuance of Clean Report of Inspection and Analysis (CRIA) issued by NAFDAC approved Clean Report of Inspection and Analysis agents. This moratorium commences from May 1, 2022 and ends on October 30, 2022.
Several prescription medicines manufactured in India and registered in Nigeria are being exported with outrageous unapproved pictorial representation and change in product formulations.
Nigerian importers
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, stated NAFDAC in a statement.
The Nigerian drug regulator has recently written to the Pharmaceuticals Export Promotion Council of India (Pharmexcil) stating that the manufacturers from India are following 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 NAFDAC has called them to ensure strict compliance to its registration guidelines, labelling and good manufacturing practice regulations as the products were registered.
“All prescription only medicines (PoM) and other categories of pharmaceutical products must strictly follow NAFDAC approved formulations and package designs,” it said.
The Nigerian drug regulator further stated that all manufacturers and exporters who are in doubt of the approved formulation and package design presented to them by Nigeria importers can reach out to it.
Any violative product that is boarded on airlines or shipping vessels from November 1, 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, said NAFDAC.
Pharmexcil has requested that member companies to adhere to the directions of the NAFDAC for hassle free exports from India to Nigeria.
The Council is also proposing to hold a virtual conference to understand the guidelines framed by the NAFDAC and the same will be communicated.
India exports of pharmaceutical products to Nigeria was US$ 564.92 million during 2021. Nigeria is one of the top five pharma export destinations of India. The other four are the US, UK, South Africa, and Russia.
Nigeria is facing a massive problem of imported substandard drugs. The African country heavily depends on drug imports.
It imports at least 70 percent of its drug requirements. India is one of the largest exporters of pharmaceutical drugs to Nigeria. This is not the first time Nigeria has raised a red flag against Indian pharmaceutical companies.
In October 2020, Nigeria’s drug regulator had blacklisted Gujarat-based Mars Remedies for manufacturing substandard antibiotic, ciprofloxacin, while accusing the drug maker of lacking transparency and quality.
FAQs on drug exports from India:
1. What are drug exports?
Drug exports refer to the international sale and shipment of pharmaceutical products from one country to another for various purposes, including medical use, research, and commercial distribution.
2. Can all drugs be exported without restrictions?
No, not all drugs can be exported freely. Some drugs may be subject to export restrictions or require special permits due to their nature, potential for abuse, or international agreements.
3. Are there specific labeling requirements for exported drugs?
Yes, exported drugs usually need to have clear and compliant labeling that meets the requirements of both the exporting and importing countries. This includes information on ingredients, dosage, and safety warnings.
4. What documents are needed for drug export?
Commonly required export documents include a Certificate of Analysis, a Certificate of Origin, a Bill of Lading, a Packing List, and the necessary licenses or permits.
5. How are drug quality and safety ensured during export?
Quality and safety are maintained through adherence to Good Manufacturing Practices (GMP) and compliance with international quality standards. Regular inspections and audits are conducted to ensure product integrity.
6. Can pharmaceutical companies export experimental drugs for clinical trials?
Yes, pharmaceutical companies can export experimental drugs for clinical trials, but this process is highly regulated and requires approval from regulatory authorities.
7. Are there export incentives for drug manufacturers?
Some countries may offer export incentives, tax benefits, or subsidies to pharmaceutical companies to promote drug exports and boost their competitiveness in the global market.
8. What are the key regulations governing drug exports from India?
Drug exports from India are primarily regulated by the Central Drugs Standard Control Organization (CDSCO) and the Directorate General of Foreign Trade (DGFT).
9. Are there specific licensing requirements for exporting pharmaceuticals from India?
Yes, pharmaceutical exporters in India typically need to obtain an Import-Export Code (IEC) from the DGFT. Additionally, specific licenses and permits may be required for certain types of drugs or destinations.
10. Can Indian pharmaceutical companies export to the United States and the European Union (EU)?
Yes, Indian pharmaceutical companies can export to the U.S. and EU markets. However, they must comply with stringent regulatory requirements, including approvals from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).
11. What is the role of the Export Promotion Council for Pharmaceuticals (Pharmexcil)?
Pharmexcil is an organization that promotes and facilitates pharmaceutical exports from India. It provides various services and support to Indian pharmaceutical exporters.
12. Are there tax incentives or benefits for pharmaceutical exporters in India?
India offers various export incentives and tax benefits to pharmaceutical companies to encourage drug exports. These incentives can include the Duty Drawback Scheme and the Export Promotion Capital Goods (EPCG) Scheme.
Disclaimer: This article contains information derived from ET Healthworld. Our team utilized an AI language model, to rewrite and present the news / article in a unique format.
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