Good Distribution Practices (GDP) is the latest mandatory requirement in the WHO (Geneva) current Good Manufacturing Practices (cGMP) guidelines. cGMP is the upgraded version of GMP. The WHO GMP certification is mandatory for any Indian company that wishes to export its products to the semi-regulated markets.
As per the latest requirement, the upcoming new WHO GMP plants in the country should incorporate the requirements needed for the maintenance of GDP as framed in the latest guidelines. Also the existing WHO GMP certified plants should satisfy the GDP requirements to upgrade their WHO cGMP status.
The GDP requirement focuses on better storage and transportation of drugs from the factory premises to the port and from the port to the country where the drugs are to be exported. As a result these drugs reach their destination in a safe and clean way, without losing their efficacy even in a slight way.
"As per the new requirement, right from the factory premises, the vehicles used to transport the drugs to the port, the storage facilities in between and the container used for the shipment has to be GDP certified. The companies hiring exporters, transporters or logistics agents would have to ensure that they meet these requirements," said Dr. P.G. Shrotriya, director technical, MJ Biopharm Pvt Ltd. Dr. Shrotriya is having four decades of working experience in manufacturing and quality control in various companies including Ranbaxy, Warner Lambert and Ceiba Geigy.
The vehicle used in the transportation has to be maintained clean. A cold chain is a must for temperature sensitive products. The storage points have to be hygienic. All the activities have to be properly documented, as per the latest norms, said Dr. Shrotriya.
"An important feature in the latest WHO GMP guidelines is recording the temperature at definite intervals for temperature sensitive products. Data loggers need to be installed in the transportation medium, which is programmed to measure and record different parameters like temperature and humidity during regular intervals. The data collected will help one in understanding as to how much time the product was exposed to unwanted temperature," he said.
Major companies like Ranbaxy, Dr. Reddy's Labs and Zydus Cadila, who have US-FDA certified plants today had begun their exports with the WHO GMP accreditation. The trend is catching up with more medium size pharma and life sciences companies getting WHO-GMP certified. Companies like Bharat Biotech, Shantha Biotech and Panacea Biotech are in the process of getting WHO GMP accredition.
"Post 2005, two options would be available for Indian companies. Either join the generics bandwagon or concentrate on non-regulated and semi-regulated markets. Most of the medium size pharma and biotech companies are looking at the second option of getting a WHO GMP accreditation and begin their exports to developing markets," said Dr. V.V.L.N. Sastry, country head, First Call India Equity, an advisor to several FIIs and hedge funds.
"Serum Institute is a good example of a company which has increased its turnover by four folds after being accredited with a WHO GMP certification," said an industry observer.