The next time a visit to the chemist is necessary to buy a generic drug like Ranitidine, keep in mind that the quality of the drug may differ from manufacturer to manufacturer. While most of the samples of these drugs, especially those made by big pharmaceutical companies go through rigorous in-house quality checks, smaller companies may not bother with those regulations at all.
A generic drug refers to any drug that is sold under its chemical name, instead of a brand name. It is a copy of an original drug whose patent has since expired. These drugs are over 80% cheaper than their original versions, because there is no research and development required anymore to manufacture the product. After getting an approval from the Central Drugs Standard Control Organisation, any drug manufacturer can make and sell the drug.
“A while ago, a medical representative (MR) had provided us with samples of a generic eye lubricant, which is used to treat the dryness of eyes. A few of my patients, who were prescribed the drug, soon came back complaining of eye infections. We sent the eye lubricant for culture and it was positive for fungus,” said an ophthalmologist at one of the leading government hospitals in Delhi.
“The fact that the infected samples could reach a doctor’s office from a manufacturer tells you how relaxed the quality checks are for these drugs,” the ophthalmologist added.
MRs are the contact between pharma companies and doctors. They are sales professionals promoting product awareness and delivering product samples to doctors. Medical representatives are often a doctor’s only source of information about the latest drugs. If an MR of a pharma company fails to persuade a doctor to hand out the samples of his company’s drugs, the next move is to talk to the chemists.
The chemists are offered very high profit margins to sell these drugs, “which creates a pharmacist monopoly because a chemist will look at margins, not at the quality of drugs and sell generic drugs from bad companies,” said a doctor under the condition of anonymity.
“A generic drug like Moxyfloxacin, which is used for the treatment of pink eye or conjunctivitis, may be manufactured by over a dozen companies. Most of these are effective, but bad quality samples are also there. The chemist decides which one to hand out to the patients. A big pharma company will not give a high profit margin to a chemist, but a bad manufacturer often will,” added the doctor.
Often, in order to coax a doctor to keep their samples, MRs offer some incentives to sweeten the deal. “Carrots are dangled before the doctors. They may be told that their conference tickets would be booked if the samples are kept. I have seen many doctors outright refuse suspicious samples despite the incentives. Others take the incentives, but do not hand out the samples in return. However, there is a percentage of doctors who do keep bad drug samples in return for the gifts,” said a junior resident doctor from a Centrally governed hospital in Delhi.
An MR for Cipla confirmed that while big companies like the one he works for go through multiple quality checks for each batch of medicine which hits the market, many small companies do not conform to the same principles.
“It often comes down to the mindset of the doctor who has been approached by an MR trying to sell bad drugs. A registered doctor will mostly refuse the MR despite huge incentives, because they know that once a patient realises the medicines prescribed by him are not effective, they will never come back. No doctor wants to lose patients or risk his reputation like that,” said the MR.
He added: “In rural areas, where people are mostly uneducated, it is very easy to sell bad drugs to them because of the lack of awareness about healthcare. However, in the cities, people have protested and such small-time manufacturers have also been sued.”
However, an ex-medical representative, who is now into the wholesale medicine business, said that it is rare for a manufacturer to sell bad quality drugs knowingly. “Why will a pharmaceutical company risk their licence? These medical licences are given for the production and sale of generic drugs after thoroughly checking the risk factors. Companies know that a complaint can destroy them. When I was an MR, I knew that the companies I worked for always quality checked their drugs before they hit the market. Random samples from every batch are selected for checks and if they pass the test the batch is released for sale,” he said.
He confirmed that doctors may be given incentives in order to persuade them to favour a particular company’s drugs. “A company does what it has to in order to survive the tough competition. For example, if 10 MRs from different companies approach the same doctor about the same generic drug, it is obvious that the doctor will be more inclined to take the samples of the MR who has also included some gifts in the deal. The doctor, however, does not take the samples if he thinks they may be bad,” he said. Offering gifts and other incentives to doctors in return for the sale of a manufacturers’ drug samples has been identified as an unethical trade practice and is illegal in India.