May 20, 2008

Health Minister to conduct study to find spurious drug circulation

The Union Health Ministry has rejected the possibility of a large number of spurious drugs circulating in the country as suggested by some estimates, saying it would conduct a fresh study to find out the exact amount of fake medicines.

A recent study by ASSOCHAM had fixed the chunk of spurious drugs at 20-25 per cent of the total medicine circulation in the NCR region alone.

However, health ministry officials told that when asked to clarify as to how they reached the figures, ASSOCHAM said it had arrived at the figures after going through the amount of business lost by pharmaceutical firms.

The officials said that the only reliable study so far was the one conducted by the World Health Organisation (WHO) which pinned the counterfeit drugs at 3.1 per cent.

But in this study as well, the sample size taken was only 10,000 which is very low, which cannot give a true picture, they said.

The government's own data compiled over a period of 10 years shows that as many as 122 out of 150 samples were found to be normal.

The data compiled by the government is based on the complaints made by consumers following which inspectors pick up samples from various chemists to the tune of nearly 4,000 every year, they said.

The sample size for the new study would be minimum 31,000, the officials said adding that it would be conducted with a budget of Rs 50 lakh.

The study will begin in about three weeks time and will be completed in six months.

The Mashelkar committee, which studied various aspects of the growing threat from spurious drugs, in its interim report has recommended stringent punishment for offenders.

The case of an offender, according to the committee, should be tried by the court of the rank of a session judge or above whereas the extant provision provides for a trial by a metropolitan magistrate or a first class judicial magistrate or above.

The committee also noted that most cases relating to spurious drugs remained undecided for years, while suggesting a separate provision for speedy trials of such offences.

The Indian pharmaceutical industry has a domestic turnover of more than Rs 20,000 crore and exports over Rs 10,000 crore.

It has been growing at the rate of over 10 per cent for the last decade and is said to be the fourth in the world in terms of volume.

1 comment:

Anonymous said...

I am a social activist in Orissa. What have seen in the state is gives me vertigo. It is actually the Drugs Control officials themselves who are actively promoting the Spurious drugs for pecuniary benefits. Here is an example of such a character.

SPURIOUS DRUGS RACKET IN ORISSA FLOURISHES UNDER SENIOR DRUGS CONTROL OFFICER WITH POLITICAL PATRONAGE.


A. INTRODUCTION AND BACKGROUND.

Sri Hrushikesh Mahapatra was transferred from Keonjhar and posted at Cuttack in 2001 as Drugs Inspector ( from now on will be referred as DI ), Cuttack -I. Despite of detection of a Spurious drug factory running in his area with his full knowledge in 2003, he was only posted to DI, Cuttack-III Range; while continuing at Cuttack. Yet again, although he was promoted to the grade of Assistant Drugs Controller in 2005 and transferred to Bhubaneswar, he continued to remain in additional charge of DI, Cuttack for two years till June 2007 under the direct customized official orders of the than Health Minister Sri Bijaysri Routray, even though two other DIs are posted at Cuttack to perform the same duties.
Again in June 2007, he was promoted to the rank of Deputy Drugs Controller and Posted in the State Drugs Testing Laboratory but yet again his transfer order was modified by now Health Minister Sri Duryodhan Majhi and he was posted as DDC ( Intelligence ) with additional charge of the vacant post of DDC ( Western Zone ) at Sambalpur though he is the junior most officer in his cadre; and at what cost ? It can not be a matter of coincidence that presently, he is directly supervising all the enforcement activities of the very same manufacturers, wholesalers & chemists with whom he has been linked as the mastermind of flourishing spurious drugs racket at Cuttack.
In return for these favors matted out to Sri Mahapatra, the son of the Ex-Health Minister Bijaysri Raoutray was rewarded with The C&FA( All Orissa sole distributor) by M/S Bharat Serums at Cuttack in 2005 to facilitate his participation in Govt. centralized purchase of vaccines; as the company management was intimidated to sign him up as the agent by this Drugs officials and for the same very purpose he was specially permitted to continue at Cuttack despite of his promotion and transfer to Bhubaneswar. The agency is being run proxy in the name of Raoutray’s crony and middle man one Sri Lulu Mohanty. The son of this Ex-Minister has committed fraud and now siphoned off about Ten Lakhs rupees of company stocks by fabricating bogus documents. The manufacturer is now contemplating criminal action against him. But they are put on a hold under the threat of harassments and bullying by the above Drugs official. The facts can be confirmed by verification from the said company officials.
It is relevant to mention here that Cuttack caters to about 75 % of the pharmaceutical market in Orissa as every pharmaceutical manufacturing house in India appoints a Clearing And Forwarding Agent for the entire state for distribution of their medicines; who is also under contractual obligation as The Power of Attorney holder to co-ordinate all their activities on their behalf with all Central and State Govt. revenue and enforcement mechanism and therefore legally responsible for all omissions and commissions on it’s behalf. There are about more than 250 such agents situated in and around Cuttack with several godowns to stockpile their consignments before shipping to various wholesalers located at various corners of the state. Lack of adequate vigil and control over these godowns makes them vulnerable to percolation of illicit drugs through these licit channels becoming licit by the time they reach the end user.
B. CORRUPT ACTIVITIES TOWARDS PROMOTING SPURIOUS DRUGS IN THE STATE

His exhaustive activity at in this unholy episode are as under, which ascertain the fact that the Spurious drugs racket under his patronage has assumed monolithic proportion at the enormous cost of the health of gullible underprivileged patients of the state, with 40% of them living below poverty line.
1.In 2003, a spurious drug factory named M/S Unique Homeo Hall was unearthed at Cuttack by the district administration. The unit was though only licensed for production of only homeopathic drugs, it was found to be manufacturing duplicate and adulterated Tincture Ginger and Tincture Orange by using the labels of some established existing manufactures like M/S Ultra Pharmaceuticals, Cutack and M/S Coastal Pharmaceuticals, Hyderabad. It was later observed that “surprisingly” Sri Mahapatra had given a clean chit to the same unit during his earlier inspection; thereby allowing them to carryon their clandestine activities in the heart of the city. On further inquiry, it was ascertained that this company was getting hold of alcohol from grey sources; thereby jopardardizing the health of thousands of consumers; which could have lead to mass scale hooch tragedy had it not been for timely intervention and action by Cuttack Police and Excise department. Basing on the same the Drugs Controller, Orissa had cancelled their licenses. But the licenses were revoked later in 2004 under the orders of the Health Minister and the pharmaceutical unit is fully operational now. No action was taken against Sri Mahapatra for gross negligence of his duties and abatement of the offences of manufacturing Spurious drugs, Rather than that he has been rewarded with two promotions; where as at present a criminal case was registered against Sri T.V.Rao , Drugs Inspector in Bolangir district on unearthing of a fake drug factory at Kantabanji in July 2007 and he wss languishing in judicial custody for six months. It only reflects the double faced principles of the Government Of Orissa administration and the blessings of high powered political entities is very evident.
2.In 2005 two drugs namely Rofecoxib and Valdecoxib were banned by Govt. Of India as they were found to be hepatotoxics and liver carcinogenic in nature. Despite of extensive reports from the rest of the areas of the states, the all Orissa distributors at Cuttack were allowed to drain out their stocks and no action was taken by him either to take legal action the firms or to effect drugs recall, thereby allowing the patients to consume crores of rupees of these toxic drugs as a result of his unholy nexus with some pharmaceutical manufacturing houses located in various parts of India.
3. Likewise, 56 numbers of cases were ordered against some spurious and clandestine drugs wholesalers located in and around Cuttack in March 2005. But no prosecution has been launched against them till date despite of a lapse of 3 years and these dealers continue to flourish under the patronage of Sri Mahapatra. These dealers had also supplied drugs to unlicensed retail chemists causing loss of revenue to the tune of lakhs of rupees to Orissa Govt. exchequer as each drug licensee is required to deposit a treasury fee of rupees Tree thousand five hundred rupees for issue of licenses to them. This fact has been pointed out by The CAG report for the period ending 31st March 2003 ( For the audit period 1998-2003)
4. A spurious drug factory named M/S Capwin Pharmaceuticals was unearthed at Chennai during a joint raid by The C.B.I and The Central Excise authorities. On the run, the owner of this factory transported all his spurious drugs in trucks and dumped all the stocks of approximate value of 30 lakhs rupees with some wholesalers at Cuttack. On being alerted by the above authorities a tip off, the same stocks were subsequently detected in some premises by the Drugs Control officers at Cuttack in 2005 and orders were given to Sri H.K.Mahapatra to seize and prosecute these firms. But, further follow-up actions have been subverted and these dealers continue move scot-free and spread out their tentacles in rest of the state.

During the same phase, it was also detected during raids conducted that the said firm of Chennai has once again resumed manufacturing of Spurious Drugs in a pharmaceutical unit named as M/S Milton Pharmaceuticals at Cuttack. Raw materials, counterfeit labels, packing materials and cartoons belonging to M/S Capwin Pharmaceuticals were found in the above manufacturing premises. The contraband materials were seized and the preliminary prosecution report was submitted before the court of The SDJM, Cuttack. But despite of the orders of Drugs Controller, Sri Mahapatra sat tight on the issues in the capacities of Drugs Inspector, Assistant Drugs Controller (Intelligence) and Deputy Drugs Controller ( Intelligence ) and the final prosecution has not been submitted in the court to apprehend the culprit; as a result of which the Spurious drugs racketeers got a fillip and the Kantabnji spurious drug racket is a off shoot of this deliberate blindness by him.
5. Only recently in August 2007, Govt. of India had banned hundreds of drugs as they were hazardous to public health and notified the Drugs Controller, Orissa for appropriate action. But the lists were neither circulated to the field officers nor the manufactures were instructed to take back the stock as a result of which these poisonous drugs are freely moving in the market as a part the nexus between Drugs Control officers and the manufactures who have produced these clandestine drugs to save them from incurring crores of rupees of expenses by drug recall and their ultimate destruction, in public interest.
6. On detection of Substandard drugs it is the primary legal responsibility of the manufacturer and it’s agent to immediately recall the drugs to prevent further consumption by the patients pending legal or quasi-judiciary action by the Drug Regulatory Authorities. But in the instant cases in Orissa, it has been a practice by the said distributors in Orissa to recall the stocks of sub-standard drugs and recycle them in the market in the full knowledge of Drugs Control officers at Cuttack, which is evident from the following example

“LUPIDYNE POWDER’ Marketed by M/S Lupin Laboratories was detected in Ganjam district as “Not Of Standard Quality” in 2003 and accordingly a case was filed against the erring firm in the court Judicial Magistrate. But surprisingly even after six months of above detection the same stocks were being recycled and sold by the all Orissa authorized distributor of the said manufacturer at Cuttack as detected during raids conducted by a team of Drugs Control officers assimilated from all over the state and accordingly the alleged stocks were seized by the raiding team from one M/S Vijay Pharmaceuticals. But till date the officers based at Cuttack have not instituted prosecution against this firm and the distributor despite of repeated reminders and orders from the Hon’ble SDJM, Cuttack.7.
Surprisingly the Ex Health Minister Sri Majhi himself had complained to the State vigilance department soon after taking over charge about procurement and distribution of Adulterated drugs by Govt. hospitals from one blacklisted manufacturer named M/S Trimurthy Chemicals, Cuttack as detected at Kalimela PHC of Malkangiri district as some bottles contained visible floating leaves inside them. But even after a lapse of more than one year the vigilance sleuths are sitting tight on the issue and the persons responsible for a clear-cut case of manufacture and sale of “Adulterated Drugs” under the Drugs And Cosmetics Act 1940 moves scot-free continuing production of drugs for public consumption.
8.During his tenure as DI at Cuttack Hepatitis – B Vaccines were relabeled in the godowns of Glaxo SmithKline & Beacham located at with labels of higher prices and distributed to KBK districts as detected at Rayagada. This case is under trial now.

10. His father is a retired govt. employee; who owns two palatial building at Bhubaneswar and Bargarh, On a visual estimate these buildings can be valued at about Rupees One Crore Only, which is beyond the means of any retired govt. servant. It is noteworthy to mention here that his father did not have any building in his name at the time of retirement but built these evidently utilizing the black money generated by his son. This fact has been confirmed from the preliminary enquiries conducted by a senior officer of vigilance department but they are unable to get necessary permission from the DG ( Vigilance ) due to direct intervention and pressure tactics of one or more of the personalities named herein.

Now there is a consorted effort to promote this corrupt spurious officer to the rank of Drugs Controller, Orissa by manipulating his CCR ahead of all his seniors so as to ensure that the Adulterated Drugs racket keeps flourishing in the state by purchasing OUTSTANDING CCR from the retired Drugs Controller J.P.Mishra despite of all his crimes against humanity and official irregularities at astronomical costs. And there are some top ex officials of Health Department the state who are actively abating these illegal and irregular act for vested interest.


It is noteworthy to mention here that these traders at Cuttack control 50 % of drugs distributed in the state and it is here that they mix up the Spurious illicit drugs tailor-made by them in pharmaceutical factories located at in and around Ghaziabad, Indore, Raipur, Delhi, Meerut etc and push them through their licit channels to all nook and corners of the state to make them licit under the active patronage of Hrushikesh Mahapatra. The money thus generated is recycled to bribe and silence the corrupt officers and politicians.
At this rate unearthing of a few more fake drugs factories in Orissa at far fetched rural pockets like at Kantabanji in short future looks imminent and the dark shadow of Spurious drugs looms large on the public health. This is only the tip of the iceberg and removal of Sri Hrushikesh Mahapatra from any post with direct or indirect duties in Drugs Control department will lead to surfacing many such other drug scandals. If no immediate action is taken another unexpected spurious drugs flare-up is most likely to be another stinking feather in the cap of the govt. of Sri Navin Patnaik and will definitely swing the mood of the electorate in the upcoming election; with far reaching consequences unless timely actions are initiated.

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