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FDA action plan to beef up drug regulatory system

Shardul Nautiyal
Monday, August 28, 2017, 08:00 Hrs  [IST]

Concerned over the recent spate in cases relating to patient safety like overcharging and reuse of medical devices at the point of care, Maharashtra Food and Drug Administration (FDA) is taking many proactive measures while simultaneously cracking whip on retail pharmacies for improper maintenance of records and dispensing drugs in the absence of pharmacists without proper bills.

To take it forward, Maharashtra FDA Commissioner, Dr Pallavi Darade has chalked out a comprehensive plan for the upgradation of manpower and labs to tackle non-compliance to drug rules and curb illegal sales of abortion drug and MTP kits among many other challenging issues affecting patient safety. Dr Darade in an interview with Shardul Nautiyal, gives an overview of the challenges and solutions ahead.

As the centre has sanctioned Rs 138 crore for strengthening drug regulatory system in the state, kindly tell us about your plans for taking it forward.
As a part of our manpower upgradation exercise, we have recently filled six joint commissioner posts out of the seven in the state. Maharashtra Food and Drug Administration (FDA) has a total of seven divisions with seven joint commissioners respectively who are responsible to oversee compliance to the Drugs act in their respective jurisdictions. The state regulator has also asked for 400 more drug inspectors in the existing field force to oversee compliance in a more effective way. Currently there are 161 sanctioned posts in Maharashtra and 21 in Mumbai.

Around 17 vehicles will also be added to the existing fleet as a part of the upgradation for which administrative approval has been received from the finance department and funds will be allocated in a couple of months.
We have recently got administrative approval for 17 vehicles from the state finance department and we will seek to get funds in the winter session of state legislature through supplementary demands. As a part of digitising the operations of drug inspectors in the state, tablets for the same has been purchased by the Information Technology (IT) department of the state government.

A first of its kind microbiological testing lab at a cost of Rs 4.5 crore is also coming up at the Mumbai headquarters to do microbiological testing . Besides this, administrative approval from the Finance department has been received recently and funds to the tune of Rs 17 crore will be allocated in a couple of months time for the Nagpur project for strengthening labs and manpower. Land is available and the construction for the same has started.

All the three labs in Mumbai, Aurangabad and Nagpur are being strengthened. Currently, Maharashtra FDA has only two drug testing laboratories one at Mumbai and another at Aurangabad. The drug testing laboratory located at Mumbai is accredited by the National Accreditation Board for Testing and Calibration Laboratories (NABL).

Delay in analysing not-of-standard and sub standard drugs and preparing results of drug samples could be reduced considerably with setting up of more drug testing laboratories. Effective drug recall is the major objective of setting up such drug testing labs. Drawing samples, analysing them for safety and drug recall will get a boost with the upgradation of drug testing infrastructure across the state.
What is FDA action plan on overcharging cases of cardiac stents and cases of reuse of catheters which has been rampant across corporate hospitals in the state? These hospitals are reported to have charged patients as much as 77 per cent of the retail price.
Maharashtra has flagged this issue with the central government and show cause notices (SCN) have been served to around eight corporate hospitals which were involved in the unethical practice of reusing catheters and overcharging patients subsequent to its reuse at the point of care.
Hospitals have been given 15 days time to reply to the SCNs failing which they will face prosecutions as per the provisions of the law.
A letter on the same has also been sent to the central government, state health ministry and state medical education department as well to apprise them of the unethical practice so that a policy decision could be taken forward jointly on the same and actions can be taken based on the current set of rules as provisioned under the law with reference to each department and jurisdictions.

What has been FDA action on inter-state abortion drug racket and compliance to drug rules in the retail trade?
We have in the recent past detected cases of illegal sale of MTP kits at Nagpur and Hingoli in Maharashtra following our ongoing campaign against this unethical practice. Since all the retail chemists have been given clear cut instructions to dispense abortion drugs strictly on prescription, we have been able to track illegal ferrying and sale of abortion drugs and MTP kits from outside states which were found to be done in a clandestine manner masterminded by unathorised people.
Maharashtra FDA busted another illegal abortion drug racket and lodged an FIR with police at Parbhani in Aurangabad division which is latest in the series of such cases where offenders used to stock and sell Medical Termination of Pregnancy (MTP) kits in a clandestine manner without a license.

FDA has confiscated 450 strips of non-surgical abortion medication from the premises at Parbhani and two people have been booked under different sections of Drug and Magic Remedies (DMR) Act, Essential Commodities (EC) Act and Drugs and Cosmetics Act (D&C Act)."
An inter-state abortion drug racket with its network spanning across Gujarat and Delhi was the first case in the series unearthed by the FDA team in the past in which drugs worth over Rs. 3 lakh were confiscated and three people were found contravening the provisions of the law under different sections of Essential Commodities (EC) Act and Drugs and Cosmetics Act (D&C Act).

Chemists can dispense the drug only against a prescription issued by a doctor who is registered under the MTP Act. FDA investigations have revealed the presence of a widespread distribution network which used to sell abortion medication at a high price to gullible customers. Intelligence reports indicate that private courier and transport companies were being used to ferry these medicines in Mumbai.

Based on the 37, 000 inspections done on over 76, 000 retail and wholesale premises, 607 licenses were cancelled due to non-compliance to drugs and cosmetics act and 2, 620 licenses were suspended.  


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Bhagavan P S Nov 2, 2017 8:39 PM
Why not CDSCO issue direction to all state DCs to actsimilarly.?
kailas Narale Sep 1, 2017 10:23 AM
Maharashtra FDA Commissioner,
Dr Pallavi Darade

Congelation MAHA -FDA

I am Happy with performance of FDA Maharashtra.
wide scope to improve quality management system of Drug manufacturing units .

Regulatory action required to run unit as given guideline for safety efficacy quality of pharmaceuticals

only FDA /CDSCO Regulatory authority really protect life of end-user

wide scope to regulatory inspection Biological ,Blood bank
have increase inspections blood bank to improve quality service zero risk

kailas Narale
Sr Manager QA
Pharma live expo
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