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Proposed drug ban offers Nigerians no safety net

By Sola Ogundipe
ALL is not well with the Nigerian health industry. No one knows this better than the average Nigerian. Indeed  the centre no longer holds for the nation’s drug industry and things almost falling apart completely.

This is the gloomy predicarment  confronting Nigeria today as the local pharmaceutical drug manufacturing industry is unable to rise up to the demands of the drug manufacture/distribution/supply needs of the people.

That a lot remains to be desired as far as the local pharmaceutical drug manufacturing  industry is concerned is not in doubt. Neither is there controversy that  urgent and drastic measures are desirable in bringing about  appreciable measure of order into the apparent reign of disorder in which the local drug manufacturing industry is currently enmeshed.

This scenario persists, no thanks to the dwindling fortunes of a troubled health sector  that is perpetually giving more cause for jeer than for cheer.

Things appear to have fallen apart as the centre no longer holds  for the local pharmaceutical drug manufacturing industry which remains  wanting in the areas of   research and development, capacity utilisation, near-total dependence on importation of raw  materials, faulty regulatory environment, a chaotic drug distribution process and proliferation of spurious, fake, substandard and adulterated drug products, to mention just a few.

Recent baseline reports by the World Health Organisation  (WHO) put together in conjunction with the Federal Ministry of Health, paint  a gloomy  picture of the nations’s local drug industry, with the inglorious rating of the country with the highest drug prices in the world.

Also, in February this year, a report published by  the Business Monitor International – a reputable business magazine based in the United Kingdom, rated  Nigeria’s pharmaceutical  industry  15th (ahead of Zimbabwe and Kenya) amongst 17 countries considered key in African and the Middle East regional markets and in the entire world.

The study  which examined numerous aspects of each industry scored the nation low in terms of  strengths, weaknesses, opportunities and threats (the SWOT assessment),  also gave Nigeria the thumbs down on risks on return on investments; disease prevalence against drugs availability; the counterfeit market; Research and Development; drugs distribution system; domestic production, regulatory regimes and essentially pharmaceutical drugs pricing, among others.

Indicting as this Report was, worse was to come. The gloomy outlook is made more grim by the dark clouds of uncertainty that have gathered in the wake of a proposed ban of a fresh set of eight classes of imported drugs.

The drugs in question are ampicillin capsules and powder; amoxicillin capsules and powder; chlorpheniramine tablets and syrup and ascorbic acid tablets and syrup.

Others are tetracycline capsules,  ibuprofen tablets, glucose (5 per cent) and sodium chloride infusion.

Nevertheless, concerned stakeholders and close observers of the industry are unrelenting in crying foul.

Repeatedly, they are questioning the rationale of  an additional ban on importation of essential drugs when the local industry is yet ill-equipped and incapable to meet local requirements.

Trailing the knotty issue of this  proposed ban are series of agitations and raised dust  that dovetails  into a common front from vitually every angle. The verdict is  unanimous. The feeling amonst majority of stakeholders is that the idea of placing additional  drugs on the importation prohib ition list is not only faulty, ill-advised and uncalled for.

This position is not one to be dismissed with a wave of the hand, particularly when it comes to mind that the proposal is an unexpected follow-up to the set of 17 drugs placed on the Import Prohibition List (IPL) of 2005.

It may be recalled that it was in the bid to promote attainment of self-sufficiency in local manufacture of essential drugs, that former President Olusegun Obasanjo set up the Presidential Committee on the Pharmaceutical Sector Reform (PCPSR).

The body was tasked with the role of increasing local manufacture of essential drugs including Artemisinin Combination Therapies (ACTs) and Anti Retrovirals (ARVs) towards supplying a minimum of 75 per cent of local requirements. The other expectation of the PCPSR  was to sanitise the chaotic dug supply system.

In the  foreward, of its Report submitted in 2008, the PCPSR  applauded  the 2005 fiscal policy which placed 17 drugs on the Import  Prohibition List (IPL) as a boost to local production and self-sufficiency in drug production.

Further, the Report, entitled Report of Nationwide Assessment of Installed and Utilised Capacity of the Local Drug Manufacturing Companies, acknowledged that 85 per cent  of the top 20 recommended a ban on a specified list of imported drugs pharmaceutical manufacturing companies in the world were Indian companies whose products were accepted and exported all over the world including the United States of America and Europe.

But observers are quick to note that drug imports to Nigeria (most of which come from India) are roundly condemned as spurious. Specifically, concerned  Nigerians  are  querying the constitution of the PCPSR which as a group  favoured  the ban on drug importation in its report

It was gathered that not all bonafide members of the PCPSR  were carried along in the recommendation  process of the Report, which it (PCPSR) jointly authored with the Federal Ministry of Health (Department of Food and Drug Services).

Investigations revealed that, originally all stakeholders were part of the PCPSR. These included the Pharmaceutical Manufacturer’s Group of the Manufacturer’s  Association of Nigeria (PMGMAN); the Nigerian  Association of Industrial Pharmacists (NAIP); The Association of Pharmaceutical Importers in Nigeria (APIN) and the National Association of Community Pharmacists (NACP).

Regulatory agencies such as NAFDAC, the Pharmaceutical Society of Nigeria (PSN) and the Pharmacists’ Council of Nigeria (PCN) and other stakeholders were also included. However findings showed that only the PMGMAN was involved as a business interest group. Others were sidelined.

Records show that stakeholders notably, the APIN, have at various times raised concerns about the intended ban in attempt to correct the indicated lapses. Earlier, in an open letter to immediate past Minister of Health, Prof. Babatunde Osotimehin, the APIN recalled  how stakeholdres were left out prior to the banning of essential drugs in 2005 – a development it recalled led to scarcity, price hikes, adulteration as well as other sharp practices that go hand-in-hand with drug scarcity.

Worse still, the move effectively sabotaged efforts by the NAFDAC to ensure seamless transition from importation to local manufacturing, which, at that time, had  begun to yield the desired result.

Also, it remains a matter of concern that to date, no  official record exists either in the NAFDAC or at the Bureau of Statistics to back up the claims made in the PCPSR Report, especially on the eight items recommended for the ban.

Although the Report articulates the problems of local manufacturing such as sole dependence on imported raw materials and excipients, low R&D activities; poor capital base; non-functional petrochemical industry, etc; it fails to indicate imports of finished products as one of its problems. The report actually showcases the inadequacy of local production (see box below left).

A careful look at the Report indicates that the 49 firms visited in the study were not actually audited but merely inspected, yet there are over 100 registered members of PMGMAN, all of which should have been covered to ascertain actual local capacity.

Stakeholders  fault the credibility of  the Report pointing to a clause therein acknowledging that some of the  respondents would not supply needed data or information.

Their argument is that a situation in which the  PMGMAN is part of the team that “audited” itself amounts to “self audit”, which in itself, is a credibility issue.

The way forward, it appears, is the need for a true audit of the industry involving all members of the Presidential Committee originally constituted.

Consensus  is that additional ban at this point in time Any ban whatsoever will not just  precipitate the present dismal situation, but further destabilise the delicate balance of the pharmaceutical industry.

Argument is that even in instances  where adequate local capacity is established, the solution is not to ban imports but to stop further registration of new brands for imports  The recommendation is that for such brands with already registered imported labels, the  way to go would be local production following the issuance of the two-term import licence granted by NAFDAC.


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