Healthcare: menace of fake and expired drugs
Some comments from the Mahatma Gandhi Center
World over, counterfeit and outdated medicines have become an enormous public health challenge. Pharmaceutical crimes from manufacture, trade and distribution of counterfeit, stolen and illicit medicines and medical devices have significantly increased. Unknowingly, people put their health, even life, at risk by consuming fake or genuine drugs that have been doctored or expired. Over the past couple months the agency for Consumer Affairs in Sri Lanka raided many drug outlets and warehouses and found evidence pointing to expired drugs, counterfeiting and falsification of medical products, packaging and associated documentation and illegal trade of medical products. No one seems to know what happened to the items thus far detected, and there is a possibility that some of them may even creep back into the market.
Fake and expired medicines often contain wrong levels -too little, too much or none at all – of active ingredients. Fake medicines may have an active ingredient intended for a different purpose or contain highly toxic substances. Most times patients do not know the quality of what they buy even when recommended by doctors and, particularly people in remote areas where there is no quick access to a medical practitioner or a pharmacy, popular medicines are accessed from local grocery traders who have no understanding of medicines or their storage requirements. Anyone can easily be deceived by counterfeit medicines as these medicines are often packaged to a high standard and they look identical to the genuine products. In many instances outdated medicines are repackaged with new expiry dates.
The Law dealing with the import, storage, sale and other related measures regarding medicinal drugs imported into the country and manufactured locally is the Cosmetics, Devices and Drugs Authority Act No. 27 of 1980. Regulations specifying the requirements and conditions to be observed by all dealers in respect of the above activities have been published in the Government Gazette Extraordinary No.378/3 of 02nd December 1985. In spite of such legal provisions to ensure public safety the standards are unfortunately circumvented as some unscrupulous drug dealers find protection from the leniency of the law or its inadequate enforcement. Invariably, one also needs elaborate laboratory tests which are costly and cumbersome to determine the authenticity of the medicine in question, and therefore, provides sufficient cover for illicit drug trade to prosper. Given the low risk of punishment and huge sums of money that can be made, dealing in fake or outdated drugs has become very attractive in this country. This involves many intermediaries and has opened up opportunities for the dealers to infiltrate official channels that regulate the procurement and distribution systems.
The Mahatma Gandhi Centre feels that the general public may not be aware of the regulations pertaining to medicinal drugs. The following information may therefore be useful:-
1. Dealers: No person other than a dealer licensed with the Cosmetics, Devices and Drugs Authority (CDDA) is authorized to (a) import any registered drug (b) manufacture such drug locally or (c) engage in the retail sale of any drug. A retail dealer of any registered drug has to be a registered Pharmacist or a person employed by a registered pharmacist. The premises in which the drugs are sold shall be equipped with proper storage facilities for preserving the properties of the drugs stored.
2. Labelling of drugs: Container of every drug imported, manufactured, processed or packed locally or sold shall have a label carrying information which include the following:–(a) approved name of the drug as found in official pharmacopoeias (b) brand name (c)list of active ingredients showing nett contents, amount of each ingredient present (d) any special storage conditions(e) date of manufacture (f) date of expiry where applicable (g) name and address of the manufacturer. Where a prescription includes a drug which has to be prepared or taken out of the original container, the retail dealer shall dispense the drug in a suitable container labelled clearly indicating the name of the patient; name and quantity of drug dispensed; dosage and directions for use and the name and address of the dispenser/chemist.
3. Date of manufacture / expiry of drugs: Every drug imported or manufactured, packed locally or exposed for sale should have a label indicating the date of manufacture and date of expiry of the drug. Any drug which fails to conform to the specified standard or the storage, life of which has expired, has to be destroyed under the supervision of an officer authorized by CDDA.
4. Sale of drugs; No drug specified in Schedule II of the regulations should be sold after the expiry of the date specified on the label, wrapper or container of such drug.(Schedule contains a list of 278 drugs)
What can be done about fake and expired drugs
1. Public level:
* Always visit a pharmacy of repute in which drugs are properly stored.
* When purchasing a quantity which is less than the entire contents of a carton, make sure that each individual card has the date of expiry printed on it. If not, please check the original container and make sure that what is to be purchased is from a pack which is within the expiry period.
* In purchasing drugs which are required to be kept in storage under a particular temperature, ensure that what is sold to you is from such a stock. (If the pharmacy is not air-conditioned it such drugs should have been stored in a refrigerator with the required temperature control).
* Always obtain a receipt for the purchases made.
2. Policy level?
* Trading in fake or out dated medical products is a heinous crime. Therefore, punishments for such crimes should commensurate with the consequences of these medicines to the personal health and the healthcare system of the country
* Ensure collaboration among the various oversight and law enforcement agencies, such as health officials, police, customs and local administrative units, is strengthened so that they can work together to curb malpractices and enforce compliance with appropriate standards from manufacturers, importers, exporters, distributors and retailers.
* Mount a large scale campaign involving the health officials and media to raise public awareness on the dangers associated with counterfeit and outdated medicines and to report through hotlines when encountered with such cases, including cases of ineffectiveness of using prescribed drugs for a given ailment. Such awareness campaigns should be extended to schools and social groupings at every village level.
The Mahatma Gandhi Centre will be pleased to coordinate this public awareness campaign provided there is sufficient encouragement for this effort from the public. The Mahatma Gandhi Centre can be contacted @ 011-2501825 email: email@example.com