Are you sure you aren’t popping a tablet that’s banned across the globe, but readily available across the drug store counter here? How aware are you about medicines that are prescribed by the doctor, but are sub-standard or sold to you after the expiry date? Chances are that you never know!
The problem of medical stores selling expired drugs is not new. But with many pharmaceutical companies trying to market newly-discovered drugs, the presence of many bannable medicines has definitely increased. Bannable, because, they are prohibited in other countries but perfectly legal in India. Worse, people are clueless about why such drugs were banned in the first place.
So, the next time you walk upto to a drug store near you, be aware that there are at least 88 drugs supposedly banned by the Drug Controller General of India, the apex body that sanctions the licence to sell drugs.
But the pharmacist might never know, or even if he knows, he might be hiding the information from you for purely commercial reasons. Poor data on adverse reaction to drugs, shortage of manpower in State Drug Control Departments and lack of an effective monitoring / regulatory system might keep things that way. With chemists acting as doctors and lay persons vulnerable to fall into medical traps, there seems to be not much hope in the horizon.
The Drug Action Forum, Karnataka is convinced that without a strong drug regulatory system, the current scenario will continue. “India has become a dumping ground for medicines banned in other countries because the drug regulation in the country is weak. A common example is the sale of nimesulide or NICE,” explains the Forum president, Dr Gopal Dabade.
The Drug Controller General of India (DCGI), he says, is in a helpless situation. “The DCGI does not have enough staff and there is no political will to regulate. On the contrary, the drug regulation authorities listen to the dictates of the drug companies.”
Lack of evidence to prove that the bannable drugs were actually banned, is another problem. “There is no system of documentation in place to check the adverse reaction to these drugs. Since there is no statistical data to prove that the drugs are actually causing harm, the DCGI cannot do anything to stop their sale,” points out Dr Shobha Rani Hiremath of Al Ameen College of Pharmacy.
Dr Dabade agrees. According to him, doctors are not inclined to report on the side-effects because of the nexus between many medical practitioners and pharma companies. There are doctors aplenty who promote a particular pharma company’s products only. “This is, of course, a global phenomenon. But the issue is of grave consequence in India because we have a huge population, which lives on less than a dollar a day,” he says.
Hopefully, the Medical Council of India (MCI)’s efforts to bring in some regulations might make a small difference. For the record, in the United States, some states have already enforced such regulations through the Sunshine Act.
Pharmacos evade ban
The dangerous trend of some manufacturing firms finding ways to work around the ban is another area of big concern. As Dr Dabade says, although B1, B6 and B12 are banned, the pharma firms introduce the same drugs in the market by combining other drugs. Neurobion is one visible example, says he.
Karnataka State Pharmacy Council (KSPC) president D A Gundu Rao says the medical fraternity in the West is much more socially committed than here. “In the West, the doctors and pharmacists do not wait for the government to ban any drugs. The pharmacy council takes a decision to ban a particular drug that is shown to have adverse reaction and this is immediately implemented. But here, despite sending a circular through the government gazette, many drugs are still available across the counter,” he says.
For instance, the paediatric dose of nimesulide ( for children below 12 years ) and the nasal congestion drug, phenylpropanolamine (PPA), which were banned by the DCGI in February, 2011, are easily available in drug stores.
The Chennai High Court had even allowed the pharma manufacturers to sell these two drugs, so as to exhaust the stocks. It has stayed the call for a ban petitioned by the Confederation of Indian Pharmaceutical Industries (CIPI), an umbrella organisation of various small pharma companies in the country. Even DCGI’s notification banning the drugs, was stayed by the court recently. Cisapride, Human Placental Extract, Sibutramine, R-Sibutramine are among the other banned drugs. Dr B R Jaga Shetty, Drug Controller of Karnataka, informs that since the Chennai High Court has stayed the ban, there will be no ban on these drugs in Karnataka as well. “The Chennai High Court has stayed the ban on the entire notification issued by the Drug Controller General of India. So until the case is resolved, the ban cannot be implemented in our State,” he explains.
There is another big reason why banned drugs are still sold in the market: Lack of communication among the pharmacists, and the absence of a registry on the adverse effects of such drugs, as KSPC registrar Bhagavan P S puts it.
“We do not have a patient oriented policy when it comes to safe usage of drugs. Only medication and policies favouring companies exist in our country.” He informs there is now a proposal to set up a ‘pharmaco vigilance’ where every doctor, medical students will have to maintain a register mentioning the side effects of the drugs prescribed by them.
Sale of substandard drugs
Availability of substandard drugs is another problem area. Raids by the Drug Controller’s office has indicated that most such drugs are manufactured in Himachal Pradesh and other northern States.
The substandard drugs, many of which are diluted forms of the actual medicine, are less efficient. Many would not have undergone dissolution tests and the coating material would not be compliant with the prescribed standard quality. Quality of drugs is also often affected by poor storage systems. Tablets that need to be kept in cold temperature are stored at room temperature.
Poor convictions
The State Drug Control department routinely carries out inspections and raids to check the quality of drugs. Last year, the Department filed 77 cases against manufacturers and sellers with 3,212 show cause notices given to dealers who sold drugs without prescriptions, batch numbers or for not maintaining bills. However, of the 598 cases pending in the courts, only 55 have led to convictions. The Department had cancelled the licences of 833 drug manufacturing units last year, for non-compliance of the rules.
While the convictions are time consuming, the Department also has another problem – lack of inspectors. To monitor 25,000 licensed dealers and 227 drug manufacturing units in the State, the existing 26 inspectors are barely adequate. Another 25 inspectors have been recruited, but the actual need is for at least 115 inspectors.
The KSPC is now in the process of collecting the email addresses and contact numbers of all chemists across the state to disseminate information on banned drugs. Karnataka has 43,800 registered chemists out of whom, only 3,840 email and contact numbers are now available. The KSPC has also proposed a Continued Pharmacy Education (CPE) programme for all chemists. Also on the cards is a Drug Information Centre offering data on drug use and safety.
To check where Karnataka stands in the drug market, the Drug Controller’s office had recently launched a drive in its 36 circles. The local NGOs were asked to pick up samples in five drug categories – cough syrups, anti-diabetes, anti-hypertension, anti-infection medicines and antibiotics and send them to labs. Spread across three days, the Rs 15-lakh project had samples collected from chemist shops, wholesale shops, and hospitals.