Generic drugs ‘need’ quality check

DECCAN CHRONICLE. | KANIZA GARARI
Published Apr 19, 2017, 12:29 am IST
Updated Apr 19, 2017, 7:21 am IST
Medical health experts say efficacy of cheaper generic drugs must be determined before they become the mainstream in prescriptions.
A former state drug controller says the government has to first improve the administration of drugs by bringing the drugs division under the ministry of health rather than under the ministry of chemicals and petrochemicals.
 A former state drug controller says the government has to first improve the administration of drugs by bringing the drugs division under the ministry of health rather than under the ministry of chemicals and petrochemicals.

Hyderabad: Doctors across the board have welcomed the move of Prime Minister Narendra Modi to formulate a law to prescribe generic medicines but say that the quality and efficacy of generic drugs must be improved and the drug controllers must ensure that only good quality generic medicines are available in the market.

A generic drug is identical — or bioequivalent — to a brand name drug in dosage form, safety, strength, route of administration, quality, performance characteristics and intended use.

Many doctors do not prescribe the cheaper generic version of a drug because it may not be efficacious. “It is not that we do not prescribe the drugs, but the major problem is the availability of good quality of drugs,” said a senior doctor in a private hospital in the city.

Apollo Hospitals has its own pharmacy that stocks both generic and branded medicines. They source most of the medicines directly from the manufacturers. A senior doctor with Apollo Hospitals said the hospital carries out independent testing of generic products before stocking them in its pharmacy. “Presently, whatever we supply from our chain of medical stores is tested and only then stored. The generic medicines which are in our pharmacy are used by our doctors as they are assured of the quality of drugs. But they would hesitate to take the same from outside. This is because some patients have reported back with the same problems when the drugs were taken from the open market.”

Doctors therefore want the government to ensure that the drug controller monitors the quality of the generic drugs. Dr K.K. Aggarwal, president of the Indian Medical Asso-ciation, says medical professionals are concerned about spurious and substandard drugs in the market, and this has still not been addressed by the government. There are only 1,800 drug inspectors in the entire country, which is not adequate to monitor the pharmaceutical industry, he says.

“To add to this there are quacks and practitioners from alternative medicine systems who dispense allopathic medicines, which has to be controlled. For this we require very strong monitoring from drug controllers in various states,” Dr Aggarwal said.

The Union health ministry in its recent review admitted that less than 0.01 per cent of drugs produced in the country are tested for quality. Given this scenario, doctors state that it will not be fair for the government to expect them to prescribe substandard drugs.

A former state drug controller says the government has to first improve the administration of drugs by bringing the drugs division under the ministry of health rather than under the ministry of chemicals and petrochemicals as at present.

“This will be the first step which will bring clarity that these drugs are used for health purposes and must be monitored by this ministry. There are also loopholes in governance of the drug controller, as state governments are not following what the central government proposes, and that gap has to be bridged,” he added.

Consumer awareness

The government must promote the National List of Essential Medicines (NLEM) so that consumers are aware that these are available at a cheaper price.

Doctors must write in the prescription which drugs are on the NLEM list and which are not.

The NLEM drugs must be available under one window in the pharmacy and those chemists who do not keep these drugs must be punished.

IMA doctors state that writing just the generic name of the drug is not helpful; the prescription must also mention the name of the company, whether it is NLEM or non-NLEM.

Writing the prescription in capital letters must be made compulsory say chemists in order to avoid mistakes that arise out of bad handwriting.

What the Act says

All services that clinical establishments offer should be displayed along with the rates in English and Telugu.

Doctors' qualification, registration number and hospital registration certificate should be displayed.

Hospitals should submit the services and price list to the Registering Authority by 1st June every year.

DM&HO can cancel the registration of a hospital if it fails to comply with the law.

Location: India, Telangana, Hyderabad

 




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