Citizens' Issues
Public Interest Exclusive
Health ministry sets up committee to examine report on irregularities in drugs approval

The ministry of health and family welfare has set up a three-member committee to examine validity of the scientific and statutory basis adopted for approval of new drugs without clinical trials. The committee has been asked to submit its report within two months

The ministry of health and family welfare has set up a three-member committee to examine the report of the parliamentary panel which had accused the regulatory body-Drugs Controller General of India (DCGI)-of favouring pharmaceutical companies by approving drugs without conducting mandatory clinical trials. The report had also pointed lapses in the approval procedure for new drugs.

Ghulam Nabi Azad, minister for health announced that the committee consisting of Dr VM Katoch, secretary and director general of Indian Council of Medical Research, Dr PN Tandon, president, National Brain Research Centre, (department of Biotechnology, Manesar) and Dr SS Aggarwal, former director, Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow will examine the validity of the scientific and statutory basis adopted for approval of new drugs without clinical trials.

The committee has also been asked to outline appropriate measures to bring about systemic improvements in the processing and grant of statutory approvals and suggest steps to institutionalise improvements in other procedural aspects of the functioning of the Central Drugs Standard Control Organization (CDSCO). The committee has been asked to submit its report within two months.

The report tabled in the parliament on 8th May by the Standing Committee on Health and Family Welfare pointed the laxity in India's drugs regulation and stated that the DGCI is approving one drug every month without trials.

Based on information provided by the ministry, the panel said that 31 new drugs were approved in the period between January 2008 and October 2010 without conducting clinical trials on Indian patients. It also said, "There is sufficient evidence on record to conclude that there is collusive nexus between drug manufacturers, some functionaries of CDSCO (Central Drugs Standard Control Organization) and some medical experts." The CDSCO is headed by DCGI.

The panel revealed that many such drugs which are banned in developed countries like the US, UK, Australia are sold in India. The panel, which investigated and reviewed the drug regulation in India for 18 months, randomly picked up 42 medicines for scrutinising its approval status. Apart from approving drugs without mandatory clinical trials, the panel found that in case of Novartis' Everolimus, UCB's Buclizine, Eli Lilly's Pemetexid and Theon's fixed dose combination of Pregabalin, no expert opinion was sought and they were approved by the non-medical staff of CDSCO. While in case of case of 25 drugs opinion of medically qualified experts was not obtained before approval.

The report also mentioned that pharmaceutical majors like Ranbaxy, Cipla, USV and Lundbeck are advertising prescription drugs, falling under Schedule H, which is not permitted in India. (Advertising of prescription drugs by pharma companies shocks govt panel)




5 years ago

Angispan-Tr is a drug for cardio-vascular diseases. The capsules are usually prescribed, depending upon the condition of the patients, once/twice/thrice a day. In other words, any patient, at any one time, is required to procure 30/60/90 capsules for one month.
Until 2004, the medicine was being sold in packs of 50s, with all retailers refusing to sell 30/60/90 caps to any user. In other words, a buyer was being forced to buy either 20 caps more, or 10 caps less or 40 caps more as reckoned with the prescribed 30/60/90 caps a month.
The matter was referred to the Dy. Drugs Controller of India, South Zone, Shastri Bhavan, Annexe (II Floor), 26 Haddows Road, Chennai-600006. By a letter No. 34/SZ/2004-921 dt. 11.05.2004, he referred the matter to the Commissioner, Food and Drugs Control Admn., Gujarat, with a copy to the Dy. Drugs Controller (India), West Zone, Mumbai (exact postal address NOT known).
Later, without any concern for the actual users, the company changed the packaging and started selling the drug in packs of 25 caps, with an increase in price. In other words, the actual users are now compelled to buy, at a time, either 5 less (one pack) or 20 more (two packs), 10 less (two packs) or 15 more (three packs), or 10 more than the prescribed dosage of 30/60/90 respectively.
This would clearly appear to be a restrictive trade practice and against the interests of actual users, since retailers refuse to sell as per prescriptions. The Drug Controller also does not appear to have acted on the reference made to him in May, 2004. This was also taken up with a few consumers’for a who also did not care to act!
Thus, while the Drug Controller’s office never bothered, the company also kept following its own business model as usual! What then can be expected of this committee?
It is thus no use blaming the drug manufacturers who will show thousands of reasons for their packaging and pricing strategies. But is the govt. really concerned?
May I refer to a very brilliant analysis in the Sakaal Times: to all your readers in this context?

Life Exclusive
Beginning hotel life at the Courtyard

Though the author had stayed in some of the top hotels in the world as a guest, this was the first time he was on the opposite side of the table, taking care of the guests. The 32nd part of a series describing the unknown triumphs and travails of doing international business

In line with my appointment, I came to the Crystal City Courtyard, to meet Krista Webster, director of human resources. It was a general review of what we had discussed the previous day and about half an hour later, met the deputy general manager and the front office manager. The exchange was pleasant; they asked me if I wanted any lead time for giving a notice to my present employer. I had already told Krista that I was ready, willing and be able to report for duty the next morning!
I reported for duty the next morning at 0645 hours, but nobody knew anything about me, until the manager on duty turned up just about 7am. I was introduced to a young girl, by name of Linda, who was the supervisor on duty and who was to induct me in the various job responsibilities that had to be taken care of. I had taken care to bring my own note books to write down the various steps that had to be taken at the front desk. The first step was to take me around the hotel, which had some 242 rooms (almost four times the Travelodge capacity); the rooms were well done, and facilities excellent, and their charges were just as higher!
By the time we had finished the basic work, it was almost lunch time. Linda took me to the staff canteen and it was a good spread, unlike the experience I had earlier. Half an hour later, she had to punch her card out, and I was told that mine would be given the next day, and my training continued. By about 2 .45pm, the afternoon shift staff turned up, and the handing over process by the morning crew began; by 3pm the new staff were in position and handling the incoming guests.
In the morning session, I saw the process of checking out guests; and in the afternoon, guests began to arrive.  Our hotel was next to the airport, less than a mile away, and we had a shuttle service, which collected our guests regularly at thirty minute intervals. Our shuttle drivers not only collected and dropped the guests at the airport, but also handled their baggage until the check in point, when the front desk crew took over. All these actions took place in great spirits and in the friendliest manner. As the eager beaver doing a new job in a large hotel, I was furiously making my notes, observations and to many incoming guests, I had to tell them shyly that I was a new trainee, learning the operations!
When I returned back home, I got the message that the other two hotels too had called and Hyatt asked for a final interview, while, Days Inn's manager informed me that I was on their wait list for the next vacancy. The next day, after my duty was over, I walked across to Hyatt (which was next door) and informed them that I have accepted an offer from the Courtyard, and had began my work.
By the end of the first week, I was on the job and on the front desk operations.  My other colleagues were very friendly and helpful; I had no time to breathe, and I was standing on my job all the time! Only, much later, may be a couple of months, when I was told that the management had "test runs" by their own senior staff to check how I was actually faring in dealing with guests, and thankfully they had no complaints; in fact, they were surprised that I could handle difficult situations well.
Bill Harwin, our afternoon shuttle driver to the airport and near by restaurants, etc, had called off and Linda asked me if I could take care of the shuttle runs. As part of the training, I had done that too, but this time it was for real and I had to make the runs to and fro from the airport; collect and deliver the guests at Gate No 5 and No 9, bring them into the hotel, carry their baggage and deliver them to the front desk!  This was a profitable experience, as many of them gave tips!
I think the management was trying to find out a "suitable fit" for me; finally I was allotted the afternoon shift, starting at 3pm and ending at 11pm. In the meantime, my wife was equally fortunate to get a job in a school, as a care giver for young children. She worked in the morning shift, leaving home by 6am and returning back by 3pm. This sort of timing suited both of us perfectly.
One fine afternoon, we went to the Nissan showroom and picked up a new car in less than one hour and drove it back home. Our apartment in Dorchester was part of huge complex of many, which included swimming pool, gym, etc. It was in quiet neighbourhood. As the crow flies, it was less than two miles away from the famous Pentagon complex!

I think it was around this time, my wife decided to return back to India for a holiday; she went there to meet our family (my ageing parents) and hers, but returned back after a good six months, just in time before expiry of her permissible overseas stay. Green-card holders were not allowed to stay more than six months at one stretch, unless they had complied with certain formalities and were entitled to this absence due to overseas jobs, etc.
On the very first day, we had got this new car and parked it right in front of our apartment, having notified the security and got clearance to do so, because all cars parked had to have ID tags issued by Dorchester, we got into trouble, as the car was 'towed' away by the parking security people. It was a shocking experience, but after the big noise I made, I went with the security, and got the car released, without a fine, and reported it to office.
Meanwhile, our son was working with the aviation company and had a few friends, who were bachelors like him and they were subject to my cooking spicy Indian curry and rice!  Most of them were from Vietnam, Thailand, and Pakistan, apart from locals, but luckily they enjoyed my fare! In fact, I used to get his lunch prepared and this was look forward to by his colleagues!
Though it was a nice community, all owned by the same family, because of the market conditions, I suppose, they simply raised the annual rent by a 10%. In the meantime, our son moved to Washington DC itself, to be closer to his office where he worked long hours. We asked for a change in our apartment, which was even more secure with centralized door locking systems. We moved to the new apartment and within the next few months, we received the notice for another increase by 10%. When I raised the issue, I had a typically blunt answer, "take it or leave it", as "we have a long wait list" to fulfil!
Quietly, we began to work out the alternatives; luckily my wife was able to obtain a suitable position in Fort Belvoir, a ministry of defence establishment, in Alexandria. She began to attend it by bus, which sometimes took almost 45 minutes travel time each way.
In the meantime, two things happened in the hotel. I did not know that I was one of the many candidates nominated by the hotel to the Hospitality Superstar contest conducted by the Arlington County to encourage tourism. I received the 2000 Hospitality Superstar Award "in recognition of outstanding leadership, professionalism, and distinguished service to the Arlington County Hospitality Industry". This was presented on behalf of the Arlington County Board and Arlington Travel and Tourism Commission.

In the same year, at the annual day function of the Courtyard, I received also the "employee of the year" award. The Courtyard continues to be a member of the Marriott family and their guest relations is summed up by each of the associate or agent, having 'pride' in his/her job, which represented "personal responsibility in delivering excellence".  Their training has been a keynote to my approach to deal with people.

 I would never forget the assistance, co-operation and guidance that I received from my colleagues, who have remained my friends to this day. It was not a bed a of roses running the front desk in a hotel; often we have had to deal with highly irate customers who have simply landed up and demanded the best of the suites or other facilities when the hotel was sold out. There were times when guests turned up and found their names missing in the booking and so on. We were trained to handle these situations, when we had to go above and beyond the call of duty. That's part of life of the agent at the front desk, cheerful, friendly and willing to serve always.

(AK Ramdas has worked with the Engineering Export Promotion Council of the ministry of commerce and was associated with various committees of the Council. His international career took him to places like Beirut, Kuwait and Dubai at a time when these were small trading outposts. From being the advisor to exporters, he took over the mantle of a trader, travelled far and wide, and switched over to setting up garment factories and then worked in the US. He can be contacted at [email protected].)



Nagesh Kini FCA

5 years ago

Great Mr. Ramdas - you richly deserve the awards! May you win many more.
Like him, in my professional travels I've had opportunities to stay in all kinds from Dharmashalas in Gujrat to 5 Stars in Delhi.
Was a statutory auditor of a hotel and flight catering establishment too. The hotel happened to be next to Santa Cruz Airport and only hotel on the Dal Lake in Srinagar.
For further reading I suggest Arthur Hailey's "Hotel". It will attest Mr. Ramdas' experiences.

Nifty, Sensex show signs of minor reversal which may not be sustained: Friday Closing Report

Expect Nifty to find support at around 4,880

Another sign of a slowdown in the economy by way of disappointing industrial output numbers for the month of March pulled the market down today. The Nifty again followed the pattern of making a lower low and lower high and ended in the negative. An overall weak macro environment may see the fall continuing. The Nifty may hit 4,880 on Monday. The benchmark has to close above any previous day's high for a possible change in direction. The National Stock Exchange (NSE) saw a volume of 62.35 crore shares.

The market witnessed a gap down opening on weak cues from Asia following a negative close in the US no Thursday after JP Morgan announced that the company had incurred "significant mark-to-market losses". The political situation in Europe also weighed down on investors. The Nifty opened 27 points lower at 4,939 and the Sensex resumed at 16,356, down 64 points from its previous close.

Concerns about the industrial output numbers for the month of March, which were to be released later in the morning, kept the indices in the negative in early trade. A lower-than-expected 3.5% contraction in the March industrial output numbers saw the benchmarks slipping further in mid-morning trade. Prime minister's economic advisory panel chief C Rangarajan opined that Index of Industrial Production (IIP) data for March is very disappointing as it had not expected a contraction in industrial output.

A weak set of corporate results added to the woes resulting in the market dropping to the day's lows.  At the lows, the Nifty fell to 4,906 and the Sensex went back to 16,234. The market was range-bound in the negative till the noon session.

Buying in select heavyweights in the post-noon session saw the benchmarks emerge into the green and hit their intraday highs. At this point, the Nifty touched 4,976 and the Sensex scaled 16,447. However, the gains were short-lived as institutional selling once again pushed the market lower.

The market closed lower for the fourth day in a row. The Nifty finished 37 points down at 4,929 and the Sensex declined 127 points to close the session at 16,293.

The advance-decline ratio on the NSE was 494:1170.

The broader indices witnessed a bigger cut with the BSE Mid-cap index declining 0.83% and the BSE Small-cap index dropping 0.91%.

Eleven of the 13 sectoral indices settled lower, led by BSE Healthcare (down 1.97%); BSE Power (down 1.40%); BSE Fast Moving Consumer Durables (down 1.27%); BSE Metal (down 1.17%) and BSE IT (down 1.05%). The gainers were BSE Auto (up 0.58%) and BSE Bankex (up 0.02%).

The top Sensex gainers were Bajaj Auto (up 3.48%); Tata Motors (up 2.66%); BHEL (up 0.84%); DLF (up 0.59%) and State Bank of India (up 0.46%). The main losers were Tata Power (down 4.89%); Sun Pharma (down 3.87%); Hindalco Industries (down 3.32%); Coal India (down 2.21%) and Maruti Suzuki (down 2.10%).

Jaiprakash Associates (up 4.31%); Bajaj Auto (up 3.74%); Tata Motors (up 2.80%); Sesa Goa (up 2.40%) and IDFC (up 1.77%) were the key performers no the Nifty. Tata Power (down 5.70%); Grasim Industries (down 3.80%); Sun Pharma (down 3.78%); Ranbaxy (down 3.68%) and Hindalco Ind (down 3.62%) dragged the index lower.

Markets in Asia closed lower on weak economic data from within the region and across the globe. China's factory output in April witnessed a growth of 9.3% against a 12% that analysts had estimated. While the country's annual consumer inflation moderated to 3.4% in April from 3.6% in the previous month, it was above market expectations.

The Shanghai Composite declined 0.63%; the Hang Seng tanked 1.30%; the Jakarta Composite fell by 0.47%; the KLSE Composite fell by 0.24%; the Nikkei 225 dropped 0.63%; the Straits Times lost 0.70%, the KOSPI Composite saw a cut of 1.43% and the Taiwan Weighted settled 1.10% lower. At the time of writing, the main European indices were down between 0.42% and 0.90% and the US stock futures were in the red.

Back home, foreign institutional investors were net buyers of shares totalling Rs317.42 crore on Thursday. On the other hand, domestic institutional investors were net sellers of equities amounting to Rs143.53 crore.

Zicom Electronics Security Systems, an electronic security company, today launched Zicom SaaS (Security as a Service). Through this service, Zicom SaaS will provide a spectrum of services from the installation and maintenance of security systems to control room monitoring 24x7 by trained professionals. The stock declined 0.64% to close at Rs38.60 on the NSE.

Prithvi Information Solutions has received the nod from the board at the EGM (extraordinary general meeting) of the company to increase authorised capital of the company from Rs30 crore to Rs100 crore. The company will go for a preferential issue 1.65 crore equity shares to persons belonging to the non-promoter category at Rs26 a share. It would also issue 5 crore fully compulsorily convertible warrants to the same category at the same price. The stock tumbled 6.36% to close at Rs16.20 on the NSE.

Mumbai-based Uttam Galva is planning to pump in Rs500 crore in the current fiscal year to make high value products. The move is expected to ramp up the company's operating margins by 2% to about 12%. The stock settled 1.70% down at Rs69.20 on the NSE.


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