Central and State authorities will have understand and find solutions to the problems and difficulties faced by regulators who check illegal activity of manufacture and trading in spurious and substandard drugs which poses a major threat to public health in India
According to the Associated Chambers of Commerce and Industry of India (ASSOCHAM), in its study “Counterfeits, Spurious & Contraband Goods: Preventive & Remedial Issues”, 60 per cent of drugs are without any active ingredient, 19 per cent have wrong ingredients and 16 per cent have harmful and inappropriate properties such as talcum powder.
The indigenous spurious medicines market has grown to Rs40 billion from an estimated Rs30 billion in 2005 as 20 per cent of fake medicines are sold across India.
India's spurious drug industry sells 35 percent per cent of its produce worldwide. Impoverished government hospitals procure about 38 percent of the spurious medicines
Drugs are essential components in the health care of public, so, the quality of drugs is of paramount importance as these are consumed mostly by the ailing patients. The circulation of spurious drugs is of great concern to everybody i.e., the drug industry, regulators, medical profession and the general public.
There are two words used more often viz.
- Spurious and
- Counterfeit drugs.
It is important to understand the problems faced by regulators in catching and punishing the companies and personnel involved in the sale of spurious and counterfeit drugs, says Dr M Venkateswarlu, Drug Controller General India, DCG(I), in an interview to an industry magazine.
Recycling: Recycling is more in case of powder injections, like beta-lactam antibiotics, which are expensive, and over-the-counter products like iodex, gripewater etc. This is usually operated by individuals who have an understanding of the pharma markets. The process involves collecting used vials with intact labels, removing the closures, filling the containers with enough material and resealing it by using hand operated sealing machines which are easily available. These activities are restricted to two or three districts and generally don’t contain any great networking.
Predominantly, it’s an individual operation and the quantity is also smaller and operations are done at a cottage level. They are distributed mostly through hospitals, nursing homes and practicing quacks.
- These operations are carried out in small places like villages or remote places in the town and the activity is rotated from place to place. Usually, it is difficult to get any link between the stocks and the person and equally difficult to get him arrested in the absence of a clinching evidence.
- There is no control or restriction on the sale of used vials.
- No restrictions on the transporters to verify the genuinity of the goods being transported by them
An individual who works as an indenting agent is not covered under any license.
- Make sale of second hand vials, by any person/ organisation, an offense.
- Every indenting agent should have authorisation for taking orders/ supplying material from a distributor/ manufacturer and also should have authorisation from the Licensing Authorities.
- Dossiers of each suspected indenting agent should be maintained by the inspectors.
Refilling and relabeling
The culprits identifies expensive branded drugs and buy cheaper drugs belonging to small companies having same composition as of the branded product, remove the labels and other packing material, affix the label of the branded product and pack it in the pack identical to the branded product. e.g. Garamycin injection. Sometimes the product may look similar to branded/ generic product in appearance, but may contain a cheaper generic drug. e.g., Indomethacin capsules relabeled as Chloramphenicol capsules.
There should be a control on allied packaging industry such as labels manufacturer/ carton manufacturer or any unauthorised printing leading to manufacture of spurious drugs should be considered a cognisable offense. Use of only printed capsules be permitted and un-printed capsules may not be permitted.