Federation of Indian Pharmacists’ Organisations (FIPO) in a memorandum to the Union health ministry and to the Drugs Controller General of India (DCGI) urged to bring about proper storage conditions for drugs in the country as it is crucial for efficacy and safety of medicines. According to FIPO, current facilities at the pharmacies, especially in the community pharmacies and in government hospitals, are not in accordance with the Drugs & Cosmetics Act. The memorandum says that medicines to be taken internally must be stored separately from medicines required for external use. Flammable liquids and gases need to be kept in a cupboard suitable for storage of such products.
“Medicine is vital for health care. Decomposition of a drug may result, on one hand, in efficacy decrease or loss, and on the other, in the possible presence of toxic degradation products which may harm health. So, a medical store must have separate lockable rooms of adequate size and facilities for categorized storage of medicines for internal use, for external use, controlled drugs, intravenous fluids, inflammables, etc”, said the letter.
While speaking to Pharmabiz, the president of FIPO, Dr R S Thakur said a vital area in any healthcare facility is the pharmacy and the pharmacists are committed to the safety of patients as their top priority. So it should be made mandatory that the pharmacy department of a hospital be made well organised to promptly supply any medicine required for diagnosis or treatment or mitigation or prevention of diseases or disorders. Generally a drug store will keep multi-sized products from packets of tablets and capsules, various size bottles and containers of oral liquids to intravenous supplies, medicines for external application and medical appliances. All these demand a storage system aimed at preserving the potency of the product and protecting them from damages caused by unscientific storage condition or improper maintenance of storage condition. These conditions are not met by the pharmacies in the government and private sectors at present, he alleged.
Demanding that the Union health minister’s attention to this crucial issue, Dr Thakur said everything related to the storage conditions has been elaborated in the letter to the minister and the association is waiting for immediate action from the authority. He said the trend toward unit dose packaging requires even greater shelf space. In addition to the standard pharmaceuticals required, new medications are continually being ordered as they appear on the market. Therefore, space must be allocated for the storage of such items with adequate facilities to ensure efficacy and safety of medicines.
Regarding the rules to be followed on storage conditions, the memorandum says that pharmacists have the responsibility to abide by the provisions of the Drugs & Cosmetics rules and the mandatory pharmacopoeial requirements to manage proper storage of drugs and pharmaceutical products. The conditions are specified under Schedule P of the D&C Rules and other sources of standard for preservation of potency during the life period of the product. All hospitals, dispensaries, health centres and wholesale or retail outlets of medicines must have a dedicated drug storage room where medicines can be safely stored. Pharmacist must conduct regular audit of drug storage facilities to ensure compliance with regulatory requirements, the letter said.