WHO-GMP certification – a Misnomer!

The Good Manufacturing Practice (GMP) is a system (and part of quality assurance programme) to ensure that the pharmaceutical products are consistently produced and controlled according to quality standard. It is designed to minimize the risk involved in any pharmaceutical production that cannot be eliminated through testing the finished product. These risks are: unexpected cross contamination, causing damage to health or even death; wrong labels on containers causing confusion, even wrong medicines reaching patient; not enough or too much active ingredient, resulting in ineffective treatment or adverse effects.

Realizing the need of building the quality of the product during the entire process of manufacturing, the first GMP regulations were promulgated in 1963 in United States of America. They are revised in 1978 and have been updated regularly. The World Health Organization (WHO) too developed GMP as a part of its obligation “to develop, establish and promote international standards with respect to food, biological, pharmaceutical and similar products”.  The first WHO GMP was developed during 1967-69 and revised it in 1975. They are subsequently revised periodically and many new additions are made in WHO expert committee on specifications for pharmaceutical preparations, fortieth report, 2006. In India, GMP, were given statutory status much later in 1988 and were incorporated as Schedule M under Drugs and Cosmetics rules 1945. This was later again revised in 2001 but implemented only in 2005 after stiff resistance from many small-scale manufacturers.

Study conducted by vigilant researchers
The study conducted by few vigilant researchers has reported ‘how the pharmaceutical companies misuse World Health Organization name and logo’. In their study, Dr. Vijay Thawani and Kuunda Garpure reported the following phrases used by the various industries: “WHO GMP/UK MHRA approved plants”, “WHO-GMP certified”, “WHO GMP certified” along with mention of “more than 100 WHO-GMP certified products”, “WHO GMP standards”, “WHO GMP (Revised Schedule ‘M’)”, “GMP certified Schedule - M compliant unit adhering to WHO GMP norms” , Using a seal of “WHO certified GMP”, “Certificate of WHO-GMP and WHO-GMP certification” together, and so on.  Even before the company is set up, the advertisements pour in:  “WHO-GMP compliance unit opening shortly!” and “setting up state-of-the-art WHO-GMP compliance formulation plant” etc.  [Indian Journal of Medical Ethics, Vol VI, No. 1, January – March 2009].

In another investigation when the authors looked at a WHO GMP certificate issued by State Licensing Authority (SLA), it is found that the certificate even does not conform to the format/model specified by WHO for issuing GMP certificate. WHO specifies that the model certificate of GMP for a manufacturing site is intended to serve in situations where a specific GMP certificate is requested by importers, exporters, procurement agencies, and regulatory authorities. The certificate format does not mention WHO GMP certificate. GMP guidelines issued by WHO are regarded as advisory in nature and may need to be adopted by individual countries. The WHO specifies the inspection procedure and report format too.

WHO inspection
The WHO inspects the manufacturing premises or sites to determine the degree of compliance with WHO recommendations, as a part of prequalification programme. The prequalification project is coordinated by WHO to help assure the quality of medicines procured by five United Nations organizations. The prequalification programme evaluates pharmaceutical products according to WHO recommended standards of safety, efficacy and quality, and assesses compliance with good manufacturing practices (GMP), good clinical practices (GCP) and good laboratory practices (GLP), where necessary. The procedure for prequalification requires detailed assessment of product dossiers and inspection of manufacturing sites. The analysis report of 30 inspections conducted during the period 2001-2004 showed several major non-compliances and some critical non-compliance in many cases. Four areas in which non-compliances noticed were: production, quality control, receipt and storage of starting materials. Ironically all the 11 manufacturing companies located in seven different states were certified as complying with WHO-GMP [AJ van Zyl, M Zweygarth, RS Summers in Making Medicines Better, 2007].

The drugs controller general of India (DCGI) being the national drugs regulatory authority needs to look into the issue of WHO GMP certification. Though the WHO recommends the validity of GMP certificate is only for two years from the date of issue and not exceeding 3 years after inspection was carried out, there has been reported move to impress the Government of India to extend the validity for 3 years. While the WHO does not recommend the issue of ‘WHO GMP certification’, but recommends the certification scheme on the quality of pharmaceutical products moving in international commerce (COPP). The COPP needs to be popularized and mandated as an assurance of quality to promote export of medicines especially to the countries where National Regulatory Authority does not have capacity to inspect the manufacturing facilities and approve products for importing into their countries. WHO-GMP certification requires discouraging as WHO specifies no such certification and there have been reports of large scale misuse of such certification!