FDA Permits Indian Pharmacists To Distribute Generics
By Lori Clapper
In an effort to encourage the distribution of generic medicines to the poor population in India, the U.S. Food and Drug Administration (FDA) is issuing prescription guidelines to pharmacists, so they can relay the new rules to doctors.
In his address at a chemist conference in India Saturday, FDA Commissioner Mahesh Zagade expressed concerns that Indian doctors most always prescribe branded medicines, even though the costs are far more than what patients can afford. In fact, in a recent study by PGI, the only tertiary care center, which caters to more than 5,000 patients in the OPD, found that branded medicines constitute 70 percent of the total drugs prescribed in India.
And pharmacists won’t prescribe inexpensive generic versions if it goes against a doctor’s prescription.
However, Zagade wants to dispel pharmacists’ fears of distributing generic drugs. The FDA’s new directives will clearly give them permission to give generics in place of their brand-name counterparts, according to the Times of India.
Earlier this month, PGI also made it mandatory for its doctors to prescribe nonbranded drugs to patients.
The organization recently documented that the median cost for brand-name drugs was $119.23, which is considered very high as compared to the socio-economic status of the recipients.
"Most of the patients cannot afford medicines, especially branded ones. The chemist shop in the emergency mainly keeps branded medicines as doctors prescribe particular brands. This new order from the director can help in keeping a check on these malpractices," a PGI senior faculty member said.
As part of the new guidelines, Zagade also added that pharmaceutical wholesalers' stockpiles will be inspected to crack down on doctors who hoard medicines.
"Doctors are entitled to keep certain amount of drugs for their patients, but some of them resort to hoarding and selling of medicines, Zagade said. “The FDA with its limited staff cannot keep an eye on all doctors. Hence it will inspect wholesalers to identify erring doctors."