The Central Government has decided to take up the issue of ban imposed by Nigeria on many Indian pharmaceutical companies with the Nigerian Government, through its embassy in Nigeria.
Eleven Indian companies were blacklisted in March 2005 by the Nigerian regulatory authority National Agency for Food and Drug Administration and Control (NAFDAC), allegedly for supplying counterfeit drugs. Before that, the same regulatory agency had banned 19 companies, of which 15 were from India and the rest from China.
The decision was taken at a meeting of the top officials from the Ministries of Chemicals and Fertilisers, External Affairs, Commerce, Health and Family Welfare and representatives from the Drug Controller General of India (DCGI) to discuss the issue. The meeting was held as per the request from the Pharmaceutical Export Promotion Council (Pharmexcil).
Talking to Pharmabiz, D.B. Modi, chairman, Pharmexcil said the association has collected data from the affected exporters, based on a questionnaire supplied to these companies. The data was presented before the meeting. The meeting decided that the concerned officials should study the regulatory environment in Nigeria and submit data to the External Affairs and Commerce ministries. Then, the issue would be taken up with the Nigerian Government, through the Indian embassy in Nigeria.
"Show-cause notices have to be served before imposing the ban and their part should have been heard by the Nigerian regulator. This did not happen and a blanket ban was imposed on them. The losses incurred by these exporters so far are huge considering the fact that NAFDAC has published details of the affected exporters in their website. This could deny them entry to other African markets as other countries also may deny them entry because of the ban in Nigeria," said Mody.
Earlier, Pharmexcil had sent an 11-member delegation to Nigeria to discuss the issue with director general, officials concerned in the health ministry, and high commissioner in Nigeria. The delegation explained to the DG the steps taken by India to ensure the quality of drugs being exported from India and explained the problems faced by the blacklisted companies. Following this, the DG appointed a four-member committee to monitor the companies and submit its observations. Some of the blacklisted companies were allowed to continue exports till December. However, Nigeria declined to lift the ban imposed on drug exports.
According to NAFDAC, more than 70 cases related to fake drugs, importation of unregistered and substandard products are currently being prosecuted in the courts of Nigeria and the regulator has launched a crusade against fake and spurious drugs in that country. NAFDAC's fight against fake drugs has also been included in the agenda for reforms initiated by the Nigerian President.