This story is from April 20, 2016

No FDA inspection at govt pharmacies in 20 yrs: Activists

FDA says it has been sampling drugs but inspections to be conducted in next two months
No FDA inspection at govt pharmacies in 20 yrs: Activists
Nagpur: Activists from NGOs SangharshVahini and Human Right Law Network claim that the Nagpur division of Food and Drug Administration (FDA) has not conducted regular mandatory inspections of pharmacies or medical stores in the government sector for past 20 years. The government medical facilities include everything from primary health centres to tertiary centres like government medical colleges.
In a reply to an RTI query sought by Sachin Khobragade of these organizations, FDA’s joint commissioner (Drugs) of Nagpur division M Kekatpure said that the FDA would conduct inspections at all government pharmacies in all the six districts in the division in two months.

Kekatpure told TOI that it wasn’t as if the FDA didn’t do anything to keep a watch on the government medical stores. “FDA does, in fact, conduct maximum sampling, about 70%, from the drug stores in the government sector. Yes,” he admitted, “I am not aware of any inspections by the administration of the drug stores in the past.” He said he had been here for less than a year and still ‘we have conducted inspections in certain government hospitals’ in Nagpur. “Actually as per rule to weed out old documents, inspection reports are destroyed after one year except in cases where the licence was suspended. But by law, government drug stores are exempted from taking licence for drugstores,” he said.
Khobragade, however, claimed that in response to another RTI query, Nagpur zilla parishad had given a list of all pharmacists in the entire district. “A majority of pharmacists in the drug stores are not qualified. They are just high school passed. Many of them, however, have been shown as having a diploma in pharmacy,” he said. To this, the FDA joint commissioner said that these were old pharmacists appointed in the 1980s. “They were all put to a test by the government and given the degree of DPharm,” he added.
As per the Drugs and Cosmetics Act, it is mandatory for the FDA to conduct an annual inspection of every drugstore, even in the government sector, to ensure that the dispensing and supply of drugs is done by a qualified pharmacist, that the medicines are stored under required conditions and that no medicines are kept in the drugstore after their expiry date. “But unfortunately, the FDA keeps only the private sector on its toes and doesn’t bother about governments sector as only the poor seek treatment in government hospitals,” claimed Khobragade.

Mukund Adewar, another activist from the two organizations, told TOI that they were keeping a watch on the overall functioning of government hospitals at all levels, from PHCs to medical colleges. “We did a fact-finding operation in some districts in Vidarbha. Based on the findings we filed a PIL (121/2013) which is still on in the high court,” he said.
However, deputy director health services (DDHS) Dr Sanjay Jaiswal said that the state health department had its own system of conducting a watch on all its hospitals about quality and quantity of all medicines as well as pharmacists.

FDA is expected to conduct at least one inspection every year of each drugstore, government or private

It is only in 2015-16 that for the first time FDA conducted inspections at ESIS hospital in city, Thermal Power Station Khaparkheda, Rural Hospital Kalmeshwar, Saoner dispensary and GMCH, Nagpur

FDA inspections can ensure that only a qualified pharmacist dispenses medicines. But in government hospitals, it’s mostly the staff nurses, who might not understand the working

and effects of a medicine, dispense

the drug

Inspections can also ensure that no expired drug is issued to patients. Unfortunately, reports of patients being given expired drugs keep coming a few times a year


End of Article
FOLLOW US ON SOCIAL MEDIA