Indian pharmaceutical exporters to Nigeria are in a dilemma as the Nigerian regulatory authority National Agency for Food & Drug Administration & Control (NAFDAC) is yet to sort out the issues related to the blacklisting of eleven Indian drug companies for allegedly supplying counterfeit drugs. The blacklisted Indian companies and Pharmexcil are of the opinion that the ban on Indian companies is based on factors other than doubtful quality of the drugs supplied to Nigeria.
As reported earlier, eleven Indian companies were blacklisted in March 2005 by the Nigerian regulatory authority. Before that NAFDAC had blacklisted 19 companies, of which 15 were from India and the rest from China.
Rajesh Dokania, director, Merit Organics said, "NAFDAC intends to grab huge money through registration. As per our re-testing we could find out that the products are not sub-standard or spurious. We have been exporting to Nigeria for many years and there was nothing wrong with our products. They are now demanding huge registration charges of $2000-$10000 for each of the branded generics product. Presently, we have stopped exporting to Nigeria and some of our products are under registration." Merit Organics has been blacklisted in March 2005.
According to Dinesh Gupta, director, Shreechem Pharmaceuticals Pvt Ltd, which is blacklisted, the action of Nigerian Government is mysterious. "The products were shipped only after strict monitoring of quality of drugs by the independent inspection agency nominated by the Nigerian authorities. The medicines were cleared by the Nigerian customs only after receipt of 'Clean findings report of inspection and analyses by the independent inspection agency," he said.
Akshay Mehta, director, Mission Pharma, one of the blacklisted companies in India, said, "We are totally confused. No one is aware of the matter. They have blacklisted us and at the same time allowed us to ship the products. They are saying the products are spurious but there is no proof to show the same. In fact they want to show that they are applying stringent norms in the sector. We have given plea to NAFDAC to bring us out of the blacklisted company on March 2005, the month in which the company was named in the blacklisted companies. We have sent three more follow up letters to them, but so far we have not received any reply."
When contacted, Dr. P. V. Appaji, executive director, Pharmexcil said that the organisation is expecting a favourable reply from the Nigerian Government and confirmed the issue is yet to be sorted out by the authorities. The companies were blacklisted not because of the substandard quality of the products, but for marketing the products without registration.
"We had sent an 11-member delegation to Nigeria and discussed the issue with director general, officials concerned in the health ministry, and high commissioner in Nigeria and the delegation explained to the DG the steps taken by India to ensure the quality of drugs being exported from India. We had explained our stand including the problems faced by the blacklisted companies. Earlier, the companies were not given any chance to explain their stand in the matter and it worsened the situation. They were satisfied with our explanation," Dr. Appaji said.
Following this, the DG appointed a 4-member committee to monitor the companies and submit its observations. Some of the blacklisted companies have been allowed to continue exports till December. Pharmexcil hopes the date would be extended soon, he said.
Four months ago, the Nigerian Government brought a rule banning import 17 particular drug formulations to Nigeria by foreign companies, detrimental to the interest of Indian manufacturers, who control a lion's share of the Nigerian market.
Other experts are of the view that the move is to help the Nigerian manufacturers to dominate the market by ousting the Indian importers. One of the aims is to increase the capacity utilisation of local pharmaceutical manufacturers in Nigeria. According to experts, local companies are not well equipped to compete with their Indian counterparts. The major problem facing the local companies is the high cost of funds from the banks. The manufacturing companies in countries like India, which is the source of many drugs in the Nigerian market, enjoy an interest rate of about 2-6 per cent from their banks, whereas the local companies in Nigeria have to pay the interest rate of around 19-20 per cent, they point out.
It will not be easy for the local companies to compete with their Indian counterparts without enough support from the government. The power supply is available only 8-10 hours in a day for the local manufacturing companies, they noted.
Some reliable sources said that the local political compulsion does not allow the director general to call back the black listing implementation immediately.
The Indian companies that were black listed include: Kamala Overseas Bombay, Vardhman Export A-188 TTC, Unibios Lab, Shreechem Pharmaceuticals, Merit Organics, Milan Laboratories, Mission Pharmaceutical, Henkish Chemical, Intermed 4GK, Wardex Pharm and Dew Healthcare. The Pakistani company is Pliva Pakistan (Pvt) Ltd.