Adoption of good storage practices is considered to be extremely important for maintaining the potency of drugs and pharmaceuticals once they are produced under good manufacturing practices. Standard manufacturing methods, known as GMP is expected to be followed by most of the 8000 pharmaceutical companies in India today after making it mandatory from 2005. The Union health ministry had taken several years of debate and discussion with the industry before notifying the same. Some of the small and tiny pharmaceutical units are resisting implementation of Schedule M norms even today. Like manufacturing standards, storage and transportation of drugs are other two vital factors that determine the potency of the drug till it is reached the ultimate consumer. Drugs whether they are vaccines, antibiotics or even analgesics have to be stored in prescribed temperature conditions to maintain their potency. The need for proper storage of drugs starts from the manufacturing units where godowns of pharmaceutical companies are located. Not all pharma companies maintain refrigerated godowns for most of their pharma products. The quality of drugs gets seriously affected during the transportation from the factory to C&F agents and wholesalers through the open trucks. During course of the journey, drugs get exposed to extreme heat conditions particularly during summer. Constant exposure to temperatures above 30 degree centigrade for a few days can substantially degrade the antibiotics and vitamins.
The Schedule P of the Drugs & Cosmetics Act specifies the temperature conditions for storage of drugs. But these provisions are not followed by most of the small pharma units and the trade. Enforcement of these rules by the regulatory authorities is hardly done in the country. Now after recent rejection of export consignments of some of the leading companies for poor quality and subsequent representation from the industry, government has started providing cold chain facilities at major airports. The government has accepted the need for exclusive drug storage facilities at airports as a priority agenda. Currently, facilities existing in five key airports including Hyderabad and Bangalore are highly inadequate because of a surge in export activity from these cities over the years. In Mumbai and Delhi, additional cold chain facilities have to be created at the airports. It is important to have full fledged dedicated pharma zones at all the major airports and seaports in line with good distribution practices to assure quality, safety and efficacy of drugs meant for export and import. In fact, the health ministry had made a proposal to set up exclusive pharma zones at the airports of Delhi, Hyderabad and Mumbai apart from a cargo zone at Nhava Sheva port. In the case of export and import of pharmaceuticals, the government has initiated some steps but at the retail level, storage condition of pharmaceuticals is pathetic. Of the 6 lakh odd retail chemists in the country, not even one percent has air-conditioned premises. Some of them, located in rural areas, do not have even a working refrigerator to keep essential vaccines and injections safe. By remaining in the shelves for weeks and months with varying high temperatures, the drugs become easily degraded. It is a matter of serious concern that regulatory authorities have been ignoring such an important issue for years. The current state of storage of medicines thus call for framing of a set of comprehensive guidelines for post manufacturing quality maintenance of all pharmaceutical products.