Need for Quality Checks

When a cancer patient does not respond to medication, a doctor suspects that it is to do with the biology of the tumour. Today, says Dr. B.S. Ajaikumar, Chairman and CEO of HealthCare Global, a chain of cancer care hospitals headquartered in Bangalore, doctors have another reason to worry - quality of the medicine. More so now than ever, thanks largely to the new norm to prescribe generic drugs. There is rising concern among doctors treating serious and critical patients that certain generic drugs may not have been put through proper cold storage or stringent quality checks.

Ajaikumar fears that the government infrastructure is inadequate to effectively monitor their quality or to check other discrepancies. "We hardly hear of licences of doctors being cancelled for malpractices," he says, adding that forcing doctors to prescribe generic drugs is certainly going to prevent major companies from coming to India, affect R&D work and eventually give rise to more spurious drugs in the market.

In fact, doctors are wary about the likely insistence by insurance companies for generic drug prescriptions. However, a leading insurance company official, who did not wish to be quoted, said such fears were unfounded as insurance companies can neither enforce generic drug prescriptions, nor refuse reimbursements.

Ideally, there should be one drug inspector for every 50 manufacturers and one for every 200 medical stores. However, it is woefully short in most cases. Take the case of Gujarat, one of the best performing states in terms of drug regulations: for over 3,900 drug manufacturers, there are only 50 drug inspectors and for around 36,500 odd medical stores across 33 districts, there are around 90 drug inspectors. This is leaving out the other requirements like laptops, vehicles and laboratories.

Ask G.N. Singh, the Drug Controller General of India (DCGI), on what is being done about this and he says, "Continuous exercise is on to strengthen the regulatory regime in the country through fresh recruitments and capacity building for creating new testing facilities. At the Central level, where we have around 200 inspectors, our proposal to double this number is under the government's consideration and a similar exercise is going on in the states, too."

Some companies in North India are reportedly obstructing drug inspectors from auditing their facilities. Singh says, while this hasn't come to his notice, drug inspectors "should always take the help of the police" and bring it to the attention of the Centre and the state concerned.

Doctors are of the opinion that the government should focus on primary healthcare centres and strengthen their infrastructure, facilitate bulk procurement of drugs and perhaps even administer them for free. Focusing on the health index goal and on reducing infant mortality (under five years) and maternal mortality should also be its top priority. These are areas where India seems to be lagging behind even its smaller neighbours such as Bangladesh and Sri Lanka.

@EKumarSharma