Increasing number of sick small scale pharma units, fragmented drug control department, lack co-ordination between various agencies, growing number of outlets in the pharmacy retail segment, sale of drugs through internet by unauthorized/illegal web sites, are factors which contribute to the presence of spurious and counterfeit drugs in India, according to Kaushik Desai, chairman, Industrial Pharmacy Division, Indian Pharmaceutical Association.

He said that spurious drug manufacture and marketing is a global phenomenon and India is no exception. Counterfeiting of commercial products has been in existence for a long time and viewed as a remunerative trade. However, its implications are serious when it is in large volumes and high value drugs. In India, trade of spurious drugs exists because tardy court procedures, trivial punishments, easy to seek bail on offences.

There is also the issue of inadequate infrastructure. While it is recommended that one drug inspector should oversee 100 chemists, the reality is 1 for 172 pharmacy outlets. The recommendations of ratios like 1 drug inspector for 25 mfg units and 1 drug testing laboratory for every 100 retailers are not adhered to, he added.

Commenting on ramification, menace and remedy of spurious drugs, Desai stated that the  term ‘Spurious’ has been loosely equivalent to the term ‘Counterfeit’.

While Spurious drug is  defined in Section 17-B of the Drugs and Cosmetics Act, 1940 as one that is manufactured as an imitation or substitute for another drug, the World Health Organization(WHO), states that counterfeit drugs are those deliberately and fraudulently mislabelled. “In our country’s drug legislation, ‘counterfeit’ is re termed as “adulterated and spurious,” he said.

The four types of counterfeit pharmaceuticals are incorrect active pharma ingredients or excipients, correct API with incorrect excipients and vice versa, re-packaged products and expired pharmaceuticals.

If the spurious ingredients are used to manufacture medicines, it would reduce bio-availability and fail to produce the desired therapeutic effect. The absence or decreased content of an active ingredient causes much of the damage as it reduces the public trust and puts patients health at risk.

Further, the spurious drug charges mar the image of pharma manufacturers and cause irreparable damage to the healthcare system too. There is also an ongoing problem of product diversion and reintroduction of expired products into the supply chain, he said.

This is where, adoption of anti counterfeit technologies like forensic techniques, serialization, overt or covert systems can prevent duplication. For instance, Pfizer’s Viagra and Lipitor use unique logos on packaging with the ink used is similar to the one on currency notes. Oriented circular with two colours printing on capsules make the products more secure and deter counterfeiters.

These efforts enhances the security of the product, combat theft and fraud, augments supply efficiencies and eliminates dispensing errors apart from facilitating recall of defective product,  pointed out Desai.