By Sola Ogundipe
ALL is not well with the Nigerian health industry. No one knows this better than the average Nigerian. IndeedÂ the centre no longer holds for the nationâ€™s drug industry and things almost falling apart completely.
This is the gloomy predicarmentÂ 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 manufacturingÂ industry is concerned is not in doubt. Neither is there controversy thatÂ urgent and drastic measures are desirable in bringing aboutÂ 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 sectorÂ that is perpetually giving more cause for jeer than for cheer.
Things appear to have fallen apart as the centre no longer holdsÂ for the local pharmaceutical drug manufacturing industry which remainsÂ wanting in the areas ofÂ Â research and development, capacity utilisation, near-total dependence on importation of rawÂ 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 OrganisationÂ (WHO) put together in conjunction with the Federal Ministry of Health, paintÂ a gloomyÂ picture of the nationsâ€™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 byÂ the Business Monitor International – a reputable business magazine based in the United Kingdom, ratedÂ Nigeriaâ€™s pharmaceuticalÂ industryÂ 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 studyÂ which examined numerous aspects of each industry scored the nation low in terms ofÂ strengths, weaknesses, opportunities and threats (the SWOT assessment),Â 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,Â 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 ofÂ 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 thisÂ proposed ban are series of agitations and raised dustÂ that dovetailsÂ into a common front from vitually every angle. The verdict isÂ unanimous. The feeling amonst majority of stakeholders is that the idea of placing additionalÂ 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 PCPSRÂ was to sanitise the chaotic dug supply system.
In theÂ foreward, of its Report submitted in 2008, the PCPSRÂ applaudedÂ the 2005 fiscal policy which placed 17 drugs on the ImportÂ 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 centÂ 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, concernedÂ NigeriansÂ areÂ querying the constitution of the PCPSR which as a groupÂ favouredÂ the ban on drug importation in its report
It was gathered that not all bonafide members of the PCPSRÂ were carried along in the recommendationÂ 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 Manufacturerâ€™s Group of the Manufacturerâ€™sÂ Association of Nigeria (PMGMAN); the NigerianÂ 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 Pharmacistsâ€™ 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 recalledÂ 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, hadÂ begun to yield the desired result.
Also, it remains a matter of concern that to date, noÂ 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.
StakeholdersÂ fault the credibility ofÂ the Report pointing to a clause therein acknowledging that some of theÂ respondents would not supply needed data or information.
Their argument is that a situation in which theÂ PMGMAN is part of the team that â€œauditedâ€ itself amounts to â€œself auditâ€, 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.
ConsensusÂ is that additional ban at this point in time Any ban whatsoever will not justÂ precipitate the present dismal situation, but further destabilise the delicate balance of the pharmaceutical industry.
Argument is that even in instancesÂ where adequate local capacity is established, the solution is not to ban imports but to stop further registration of new brands for importsÂ The recommendation is that for such brands with already registered imported labels, theÂ way to go would be local production following the issuance of the two-term import licence granted by NAFDAC.