Good manufacturing practices in Bangladesh

Md-Nasser-Shahrear-Zahedee(Md. Nasser Shahrear Zahedee): GMP refers to the Good Manufacturing Practices promoted by the WHO GMP Guidelines, implemented by the pharmaceutical manufacturers, and monitored by the regulations promulgated by the Drug Regulatory Authorities (DRA).

The regulations relating to the GMP are backed by the law of the land and require that manufacturers, processors, and packagers of medicines and other medical products and devices take proactive measures to ensure that their products are safe, efficacious, and meet the required quality standard. Failure of manufacturers to meet the GMP requirements may result in serious consequences including recall, seizure, suspension, or cancellation of the licenses, and other punitive measures.

GMP is also sometimes referred to as the cGMP where the “c” stands for “current” demanding the manufacturers to update their technologies and systems in order to comply with the recent scientific and regulatory developments. The cGMP reminds the manufacturers and the DRAs to make periodic updates to their systems and regulations.

In 1940 Winthrop Chemical Company of USA accidentally contaminated Sulphathiazole with Phenobarbitone causing the death of hundreds of human beings. The incident prompted the US Federal Drug Administration (FDA) to implement detailed control in production throughout pharmaceutical industries resulting in the introduction of the ‘Production Control Standards’ for pharmaceuticals. In 1963 the US FDA took another step ahead and made a more elaborate document on the manufacturing of pharmaceuticals and termed it the “Current Good Manufacturing Practices (cGMP)”. In 1968, the WHO initiated a process to formulate a GMP document as a standard guideline to be followed by all member states. The document was published in 1975 as the famous WHO Guidelines on the GMP.

Pharmaceutical manufacturers in Bangladesh:

There are 263 pharmaceutical manufacturers in Bangladesh producing more than 22,000 products comprising about 1,200 active pharmaceutical ingredients (API).

In the last 20 years of Bangladesh, there has been a great deal of developments in the willingness of the manufacturers to improve upon the GMP at their plants. Quite a few of them have already qualified in the GMP audits of international standards. Just in the last couple of years, the following companies have already added the laurels of being qualified in the stringent audits of the leading regulatory authorities as mentioned below:

As a result, for the last few years, there has been a strong positive trend of Bangladeshi manufacturers going global and Bangladesh has emerged as one of the top exporters of pharmaceutical products among the LDCs. Although the volume-wise figure may not be very high, the most important aspect is that Bangladeshi pharmaceutical manufacturers have spread their wings to more than 60 countries including UK and the other EU countries. The macro picture looks very promising as most of the top 20 manufacturers are in the queue of achieving similar international recognition within the next couple of years.

Besides, there are at least another 30 companies in the country that are actively investing resources to improve upon the status of GMP compliance. This is also a very good sign that ushers in an optimistic future.

From the GMP point of view, it is a matter of concern that there are 263 pharmaceutical manufacturing licenses in Bangladesh. This is a situation that imposes a serious threat to bringing the whole pharmaceutical industry to an acceptable standard of GMP or to the level of satisfying the WHO GMP guidelines.

If we take a look at the market shares, the top 50 pharmaceutical manufacturers enjoy more than 95 percent of the market share. The rest 213 manufacturers supply less than 5.0 percent of the market. Out of these 213 manufacturers, at least half of them have already turned into sick industries today and they are not in a position to invest for improvement. What is to be done with these sick pharmaceutical industries is an issue that touches the arena of political decisions. However, it is emphasized that the issue should not be kept like this any longer. The DRA and the government should look into the matter for a solution.

From the perspective of strict compliance with GMP, not many companies could be up to the mark today. Among the rest of the companies, there are about 50 plus manufacturers who, with a certain degree of technical and financial support, could significantly improve upon their current status of GMP. In order to elevate the standard of the pharmaceutical sector as a whole and in the absolute interest of the public in particular, it has become mandatory to bring these manufacturers to the fold of GMP compliance.

Should it be materialized  Bangladesh could make a revolutionary achievement in the compliance of WHO GMP guidelines. The people would be able to take their 99 percent of medicines produced under GMP and the export potential would accelerate manifold as the overall image of our pharmaceuticals at the international level would have been tremendously glorified. When the whole world is concerned with the compliance of GMP, Bangladesh can not afford to remain far behind. A concerted effort, pioneered by the government, could bring about a plausible solution to the crux.

We have so many consultants of various kinds working in Bangladesh under the umbrella of the UN bodies, World Bank, IMF, international NGOs, etc. There are also many such consultants in the health sector, as well, although not a single for supporting the pharmaceutical sector. The appointment of at least a few consultants on GMP for supporting the development of small and medium pharmaceutical manufacturers, coupled with a soft-term loan for their financing, will go a long way in improving upon the overall standard of the GMP in Bangladesh. We can not afford to miss this opportunity.

The pharmacists and other technical professionals:

Pharmacists and other technical professionals working in the pharmaceutical sector of Bangladesh have acquired a very high standard of skills and expertise in GMP. The pharmacists and other technical professionals engaged in a good number of companies are now adequately qualified in ensuring the manufacturing environment, systems, and processes including the documentation according to the criteria of GMP. There are a few thousand non-resident Bangladeshi pharmacists working in pharmaceutical plants and in R&D laboratories in the USA, Canada, Europe, and Australia. Bangladeshi pharmacists are also working with leading international consultant groups and designing GMP-compliant plants around the globe. Bangladeshi architects and engineers have already gained tangible experience in designing and erecting pharmaceutical plants complying with the requirements of GMP.

Drug Regulatory Authorities (DRA):

Assurance of the right quality of a product is the onus of a manufacturer. A manufacturer is supposed to have all required facilities, qualified personnel, and quality systems in place to assure the right quality of the products. The quality issue in the pharmaceutical sector is so important that even after the efforts of the manufacturers, there always remains a mandatory need for a competent drug regulatory authority to monitor the manufacturers and institute necessary controls where it is appropriate. Without a strong and well-equipped DRA, the expected compliance with the GMP can not be achieved. The scale of DRA’s efficiency is directly related to the standards of GMP compliance of any given country.

The Directorate of Drug Administration (DDA) is the DRA for Bangladesh. It is an organization awfully neglected in terms of resources and regulatory authority. The human resource is so inadequate that one Superintendent of Drugs (SD) covers a cluster of 2-4 districts with only one supporting clerk and shoulders the workload of supervising over a thousand pharmacies and a good number of drug manufacturing units spread over a few hundred square kilometers of area. There is only one transport in the whole organization allocated to the use by the Director and all other officers, right from the three Deputy Directors down to the SDs, are left over to the public transport for any official traveling and with almost no budget to pay for the bus fares.

Surprisingly, there is absolutely no career plan for the officers and more than 90 percent of them retire from the same post that he or they joined 30 years ago as bright university graduates, qualified by the stringent selection procedures of the Public Service Commission (PSC). No new recruitment has been made in the last 15 years although the workload has increased ten times. There is no provision for government quarters for the DDA officers and the wages are so low that they are to either eat or rent a small apartment in a low-cost area, as the wages do not allow affording both together. If the quality and the GMP could be properly monitored by leaving the DRA at such a crippled condition and whether such a system could effectively perform on the earth, a question that remains unanswered for decades together.

The DDA needs to be expanded and upgraded. It is unbelievable that there are (in total from Director to the Inspector) only 41 officers in the DDA; out of them 27 are in the field and 14 are in the head office. They need to control the registration, manufacturing, prices, and import of raw & packaging materials of over 22,000 products manufactured by 263 companies. They do also control the same tasks of over 10,000 products from more than 500 Unani, Ayurvedic, Homeopathic, and Herbal manufacturers. They are to inspect about 400 manufacturing sites every year for conducting GMP audits. They do also issue new licenses to the pharmacies, renew more than 30,000 licenses per year and monitor the activities of the 62, 000 pharmacies and another 70,000 medicine shops (pharmacies without licenses). This is simply impossible and once again reiterated, un-believable.

It was always agreed by all concerned that the DDA needs to be expanded with at least 400 headcounts and upgraded to a Directorate General. However, what has been found in reality is that the question of the expansion of the Drug Administration from a Directorate to a Directorate General has been a futile commitment of the authorities, often deliberated in the seminars, symposia, and meetings, without any ultimate outcome. In July 2006, almost all the formalities were completed to upgrade the DDA to DGDA with a total headcount of 395 persons; however, due to the reluctance of the Ministry of Establishment, the final nod of the Prime Minister could not be obtained. By all counts, the DDA requires a head count of at least 750 persons to meet the challenges of the coming days.

Bangladesh Pharmaceutical Society (BPS) and Bangladesh Association of Pharmaceutical Industries (BAPI) have been relentlessly pressing the need of strengthening the DRA for the last two decades only to witness the bureaucratic shuttling of files. As regards the current situation, it has been learned that the file for the up-gradation and expansion of the DRA is at the “final stage” and may be materialized at any moment. The current government has championed the absolute mandate of the people to take the country forward through positive changes. The Honorable Prime Minister has already shown her sincerity and seriousness to implement progressive activities for a better Bangladesh. We are confident that the expansion and the up-gradation of the DRA will take place very soon with the approval of the Honorable Prime Minister.

Drug Testing Laboratories:

A drug regulatory authority can not function without drug testing laboratories. For an effective monitoring of GMP as well, the DRA will require highly efficient laboratory support. The DDA of Bangladesh has got only one drug testing laboratory in Chittagong. The laboratory has shortages of everything — be it personnel, equipment, system, or any other resources.

For years together the professionals and manufacturers have been asking for the expansion of the lab facilities of the Drug Administration but no tangible achievement could be made so far.

It has become extremely pertinent to strengthen the Central Drug Testing Laboratory at Chittagong and also to establish at least one DTL at every Division to cater to the growing demands of effective monitoring of the quality of drugs.

Central Reference Laboratory:

The issue of setting up a central reference laboratory has been in discussion for a long. A well-equipped central reference laboratory may function as a multipurpose institution that would also extend support to the DRA and to the industry in improving upon the GMP and also ensuring a better quality system in the pharmaceutical sector. In collaboration with the leading public universities, the reference laboratory can offer opportunities for higher studies to the officers in the DRA and DTL allowing them to expand the horizon of knowledge sitting in Bangladesh. The other major functions of the reference laboratories would be to:

a.Carry on drug analyses that are not possible in the DTL; b. Perform tests as an appellate laboratory to settle differences between DRA and the manufacturers on tests conducted by the DTL; c.Offer lab support to the postgraduate research students of pharmaceutical sciences; d.Offer laboratory support to the clinical research organizations conducting bio-equivalence tests; and e.Offer lab support to other research and analytical works.

Since BCSIR is a blend of scientific and industrial research and the Pharmacy Council of Bangladesh (PCB) is the professional regulatory body, the reference laboratory could be a joint venture of these two organizations. An autonomous governing body may be formed with the representatives of the BCSIR, PCB, and DRA, to run the laboratory independently.

A regular GMP audit is a mandatory requirement to ensure GMP compliance. There was no format or checklist for the GMP audit by the DDA inspectors. In 1994, with the initiative of the Bangladesh Pharmaceutical Society (BPS) a GMP Inspection Check-list was finalized by the consensus of the DRA, BAPI, and the BPS.

It was agreed that the audits would take place with the aid of the Checklist. Unfortunately, in the last 15 years it could not be materialized  It can only be said without a GMP audit being properly conducted and documented there can not be any point in talking about the GMP.

There is no denying that for the improvement of the GMP the pharmaceutical sector requires adequate and skilled administrative support from the government. Being a technical sector, the officers in the concerned ministries involved with the providing of administrative support to the DRA and the pharmaceutical sector should have at least a sound prior exposure to the sector and an optimum understanding of the GMP.

Recommendations

The criteria of GMP should be periodically updated for furthering the safety and efficacy of the medicines and medicinal substances produced in the country. We may summarize the following recommendations for Bangladesh in order to keep pace with the developments that are taking place worldwide.

1. A document should be prepared to elaborate on the standards and parameters of GMP for the manufacturers of medicines in Bangladesh.

The document may include the modus of classification of the manufacturers based on the level of GMP compliance. A committee formed by the government with the officers of the DRA, industrial pharmacists, pharmaceutical experts, and the technical representatives of the stakeholders may formulate the document.

2. The Inspection Checklist should be followed in the GMP audit by the officers of the DDA of the manufacturers of all sorts of medicines produced in the country. This document may also be used for the self-inspection of the manufacturers to identify the deficiencies and take necessary remedial steps. The Unani, Ayurvedic, Homeopathic, and Herbal manufacturers may also use the checklist for the same purpose.

3. The DDA should be expanded and upgraded to DGDA as soon as possible. Adequate regulatory authority and administrative autonomy should be awarded to the DRA. Professionals with sufficient knowledge and understanding about the GMP should be placed at levels of officers of the DRA including the senior positions.

4. The Central Drug Testing Laboratory should be strengthened. Divisional Drug Testing Laboratories may be set up in phases. The laboratories should be equipped with modern facilities and a sufficient number of Pharmacists and other technical personnel should be appointed to run the laboratory effectively.

5. The Central Pharmaceutical Reference Laboratory may be set up with the collaboration of DRA, BCSIR, and the Pharmacy Council of Bangladesh.

This organization would offer laboratory support for the bio-equivalence tests and for other forms of research in the areas of pharmaceutical sciences.

6. The government may take the initiative to appoint an adequate number of consultants to support medium-sized pharmaceutical manufacturers in improving upon their GMP compliance levels.

The writer, Md. Nasser Shahrear Zahedee is the president of the Bangladesh Pharmaceutical Society and the Managing Director of Radiant Pharmaceuticals Ltd. (Source: The Financial Express)

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