To ensure smooth functioning and sustainability of the industry, it is essential to have a competent regulatory body that can help not only in addressing the core issues but also play an important role by contributing to its growth story. The role of a regulatory body as an enforcement agency is to ensure implementation of all the required provisions as mentioned in the law.
Larger the industry, greater the responsibility especially in a segment like pharma which deals with the life of the patients. Even a small error caused due to negligence and non-compliance of the drugs and cosmetics (D&C) act can cost a huge blow to the sustainability of the industry. This becomes even more complex when there are many players at stake like in the pharma industry which includes the stake-holders like retailers, wholesalers, chemists and druggiest etc. Their role in the drug distribution system as a key player to ensure availability of essential drugs to patients is certainly an undisputed one.
With Gujarat being a major hot spot for the pharma industry, it also is the home to one of the largest group of stakeholders. As on date, the Gujarat FDCA has granted sales licence to around 27876 stakeholders in total from across the state which includes 12852 allopathic retailers; 11855 allopathic wholesalers; 2751 homoeopathic retailers and wholesalers; 190 restricted license holder; 415 schedule X holders etc. to point out a few. They distribute and dispense drugs across the state from the urban areas to rural areas making it necessary to monitor their activities frequently.
With a view to analysing the present work ethics followed by various stakeholders in Gujarat, so as to ensure that the provisions of the drugs and cosmetics (D&C) Act and Rules were being followed by them properly, the Gujarat FDCA has launched a massive drive through out the state to crack on any illegal activities being carried out by the chemists and druggists in the area.
Raids on ayurvedic doctors
From some time now there has been a sudden jump in the number of ayurvedic doctors indulging in illegal activities of selling allopathic drugs to the patients in the name of ayurvedic medicines. This action is not only in contravention to the D&C Act, but is also dangerous which puts at risk the life of the patients involved.
To put a stop to this activities, Gujarat FDCA has issued strict warning to all the ayurvedic practitioners in the state, asking them to refrain from any activities that are in contravention of the provisions of the drugs and cosmetics (D&C) Act and Rules. The state FDCA had earlier carried out a district -wise investigation which later prompted them to initiate surprise check on around 100 chemists shops from across four major districts namely Baroda, Bharuch, Surendra Nagar and some parts of Ahmedabad. During the investigation, the drug regulators went through all the sales receipt and other trade related documents of the stakeholders so as to ensure that none of the stakeholders were involved in any activities that point out discrepant activities.
Shockingly, following the screening of some of the chemists and pharmacy shops in the said area, drug officials found that some of them have been involved in illegal activities like selling drugs to the patients without proper prescription which is in contravention of the D&C Act. Under provisions of Rule 65 of the Act, it is punishable under the law for a chemist or a druggist to dispense medicines without a valid prescription issued by a certified medical practitioner.
Dr H G Koshia, commissioner, Gujarat FDCA informed that out of the 100 chemists and pharmacy shops that have been checked till now almost 30 of the shops were found to be flouting Rule 65 of the Act, from which 20 where from Baroda, seven from Bharuch and the rest from the other areas. He further stressed that all the culprits have already been indicted for their actions and will be punished severely for their activities which are not only in contravention of the law but also against the safety of the public.
The main aim behind this drive was to bring a stop to the practice of sale of medicines by the chemists and druggists without proper prescription. This action was further spurred by the recent study conducted by the FDCA officials which showed that many of the chemists and druggists from the state were blatantly involved in the illegal activity of selling drugs, especially those drugs that aid in the termination of pregnancy without prescription.
“We have always strived to achieve our goal of ensuring public safety by propagating safe use of medicines in the state and thus we will take strict against against those who indulge in any activities that are against public interest. No consideration will be given to any of the stakeholders who try to mislead and misinterpret the law for their benefit thus putting the life of patients at risk,” Dr Koshia warned.
FDCA plans to carry out this drive as an on going process so that all the activities of the stakeholders are frequently scanned and checked regularly to refrain them from continuing such activities. The drug regulatory authority has already issued a stern directive to all the stakeholders from the state from indulging in any such activities in future and warned them of severe punishment under the law along with cancellation of their licences. This step was taken in the wake of increasing incidence of ayurvedic doctors selling allopathic drugs to the unsuspicious patients as ayurvedic drugs by changing and renaming the labels and packing the drugs as per their requirements.
As a follow-up on this, the state regulatory authority recently searched and seized drugs and other supplementary products worth Rs.11.5 lakh from two Surat-based ayurvedic skin care clinics owned by Dr Prakash Barvaliya for indulging in multiple offences that are in violation of the D&C Act. During the initial investigation the drug inspectors found Dr Barvaliya, who owned the skin care treatment centres by the name of Godfather hospital and Astitva, at two different location in Surat, to be guilty of defying section 18(c) of the D&C Act which deals with manufacturing drugs without valid license, section 18(a)6 of the Act for manufacturing spurious and substandard drugs putting at risk the life of the patients.
Dr Barvaliya was also found guilty of selling allopathic drugs to the patients in the pretence of ayurvedic drugs, which is a serious offence under the law. During the raid that was carried out on a tip off, the investigators found that Dr Barvaliya was involved in buying generic anti-fungal, anti microbial, steroid containing ointments and creams from the market in bulk and reclaiming them under the fake brand name of Asta ayurvedic product.
According to Dr Koshia, while doing these illegal activities Dr Barvaliya had been careful so as to avoid detection by faking all the required details in a very systematic manner with manufacturing and production date, batch number and details along with the name of ayurvedic ingredients used in the so called labels. Each of the products was packed in 65 grams sachets and was sold to patients directly.
Dr Koshia further informed that almost 95 substances including other drug-based raw materials were confiscated from the clinics out of which 20 samples have been sent to the drug-testing lab for testing.
“Strict action will be taken against the culprits for risking the life of patients for monetary gains. We have always tried our best to ensure the safety of the patients as our first priority, thus to ensure that such activities do not happen again. We are going to tighten our investigative techniques to a newer level. This will not only help us in controlling such illegal events in the state but also will discourage any possible mushrooming of such activities in the state in the future as well,” he added.
Earlier in the year, FDCA had busted two ayurvedic clinics selling combination of allopathic and ayurvedic drugs for various aliments in a raid carried out in two separate areas in Ahmedabad. The FDCA seized drugs worth Rs.10,30,000 from the two clinics situated in Bapunagar from the eastern part of Ahmedabad and Drive-in Road from the western part of Ahmedabad.
During the investigation, the officers found 1600 pouches of drugs without any label addressing aliments like diabetes, joint pain, de-addiction etc. In a preliminary test conducted on the de-addiction drug confirmed that the owners of the clinics Dr Raman Patel and associate doctor Arpita Shah who being an ayurvedic practitioners were dispensing combination of allopathic and ayurvedic medicines to the patients coming for the treatments of de -addiction.
According to Dr Koshia, “During our prima facie investigation, we found that these two individuals were distributing the so-called drugs of questionable standards in a sealed aluminium pouch containing a yellowish powder to their patients. In this case when the test was done on a ayuvedic de-addictive drug, the results showed that it had contents of disulfiram an allopathic drug in the powder.”
Dr Koshia further informed that since the doctors where found to be dispersing mixed combination of allopathic drugs in the pretext of giving ayurvedic drugs to the patients they have not only committed a criminal offence under the Drugs and Cosmetics (D&C) Act but have also risked the life of patients by administering a banned combination drug to them. The drug inspectors found that these centres were selling a combination of disulfiram tablets after mixing it with some ayurvedic substances, which is dangerous and an offence under the Drugs and Cosmetics Act (D&C) Act.
In another shocking incidence, last year FDCA busted a racket running a fake alcohol anonymous de-addiction centre in Ahmedabad, Surat and Baroda and seized drugs worth Rs.50,000 from the raids. The drug inspectors found that these centres were selling a combination of disulfiram tablets after mixing it with some ayurvedic substances, which is dangerous and an illegal offence under the D&C Act.
During the investigation the drug inspectors recovered about 5,000 sachets of misbranded and spurious disulfiram tablets. Out of which the authorities have already send six samples of the seized dugs for test analysis to the food and drug laboratory in Baroda.
According to Dr Koshia, “The organisers were running this centre in the pretext of giving ayurvedic treatment for de addiction, wherein they were actually found to be selling mixed combination of allopathic drug and some ayurvedic substance. On our inquiry we found that as of now there aren't any ayurvedic treatment for de-addiction and that set as up to dig further in this case.”
Upon enquiry the drug authorities found that this centre was owned by three persons namely Virendra Singh from Mohali, Dubey and Pandey from Mumbai who where providing this course of drugs for Rs.360 to any individuals with addiction to alcohol and tobacco. Says Dr Koshia,“The centres have been found of not only violating the D&C Act but also putting the lives of poor patients at risk by giving them a combination of allopathic and ayurvedic drug which is banned under the law. Most importantly during our investigation we found that they were giving the sachet containing the spurious disulfiram tables to the patients without any consultation or counselling from any doctor.”