Drug regulator finds D Cold Total, Combiflam, Oflox 100 to be substandard

When Combiflam was found to be substandard three times last year, Sanofi India had recalled the affected batches.

By: Deepak Patel | New Delhi | Updated: April 21, 2017 9:04 am
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The Central Drugs Standard Control Organization (CDSCO) has found popular painkiller Combiflam and cold medicine D Cold Total, manufactured and sold by Sanofi India and Reckitt Benckiser Healthcare India, respectively, to be substandard in its tests done last month.

Moreover, Cipla’s Oflox-100 DT tablets and Theo Asthalin tablets, as well as Cadila’s Cadilose solution have also been found to be substandard. In total, the CDSCO has issued a drug alert for 60 medicines, including five aforementioned drugs, as they failed different quality tests in March 2017.

Combiflam batch number A151195, manufactured in October, 2015, failed the disintegration test of CDSCO. In last year, the CDSCO had found Combiflam to be substandard three times — in February, April and June — for failing the same disintegration test.

Sanofi India spokesperson told The Indian Express: “Certain batches of Combiflam manufactured in 2015 were deemed substandard because the tablets showed a delay in the disintegration time. Essentially, there are several pharmaceutical parameters that are routinely assessed, one of which is to check the breakdown of a tablet in the human body. The batch identified by the CDSCO in March 2017 was also manufactured in 2015. Once we receive the official notice, we will ascertain the finding and take appropriate action.”

When Combiflam was found to be substandard three times last year, Sanofi India had recalled the affected batches. According to QuintilesIMS, a technology-driven healthcare service provider, the annual sales of Combiflam is of Rs 169.2 crore.

“In the case of these specific 2015 batches of Combiflam, although the disintegration time was delayed, doctors and patients can be assured that there is no impact on the safety and efficacy of the product. Since the matter first arose last year, we have analysed the problem and taken appropriate remedial steps to ensure that the tablets disintegrate within the specified timelines. Combiflam has been in the Indian market for over twenty-five years and continues to be a safe and efficacious analgesic used for relieving pain,” Sanofi India spokesperson added.

Cipla’s Theo Asthalin has annual sales of Rs 17.3 crore in India, according to QuintilesIMS. It has 91.53 per cent market share in its molecule category — Salbutamol Sulfate + Theophylline. Theo Asthalin failed the disintegration test last month. Cipla’s Oflox has annual sales of Rs 20.7 crore. Oflox failed the “assay” test of CDSCO last month.

In assay test, the analyst checks if the ingredients in the molecule are in proper amount and of good quality. The D Cold Total tablets of batch AD762 were found to be substandard by the last month as it failed the disintegration test. Cipla and Reckitt Benckiser Healthcare India did not respond to specific queries sent by The Indian Express.

According to QuintilesIMS, Cadila Pharmaceuticals’ Cadilose has annual sales of Rs 5.8 crore. Cadilose, which is the brand of molecule category Lactulose, failed the “assay” test of the central drug regulator. In response to specific queries of The Indian Express, the company stated: “ Cadila Pharmaceuticals Ltd has not received any communication on this development, hence it is not possible for us to comment on the same.” In India, 60 other pharmaceutical companies are selling Lactulose under different brand names.

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  1. K
    Karunakar
    Apr 21, 2017 at 8:33 pm
    Mr wadkar has a valid point. Knowingthat any business has a natural tendency to maximize profits .Moreover while pharma companies can still monitored, it will be practically impossible to monitor the chemists (and pharma companies through them.) . This move will take away the power from responsible people and put it in the hands of irresponsible business. It looks like people are going to be in trouble sooner than expected. What will happen is that the chemists will become the new doctors, as is already the case in low income areas.A very dangerous trend.
    Reply
  2. S
    Sabuj Chowdhury
    Apr 21, 2017 at 8:25 pm
    Why Drug Authority don't file Criminal case These drug company will talk about Generics quality what our PM wants to implement making more affordable. Same Pharma manufacturers
    Reply
  3. A
    Abhishek Wadkar
    Apr 21, 2017 at 3:06 pm
    Forcing doctors to write only generic name will make this matter worst ...As all action will shift from doctor to profit driven chemist...The doctor knows which b is reliable by his experience ..As against chemist who will prefer to keep those products that have max profit margins at the expense of quality ..... Ultimately patients will suffer and as usual doctors will be blamed
    Reply
  4. N
    Naresh Kumar
    Apr 21, 2017 at 1:52 pm
    Strict action should be taken it is very sensitive issue and they should be penalised if law provides for.
    Reply
  5. S
    surekha
    Apr 21, 2017 at 12:50 pm
    These pharmaceutical companies should be heavily penalised for selling sub-standard medicine in the market. The government should come down heavily. It is a very serious matter that these companies playing with the health of the people should not be tolerated at all.
    Reply
  6. C
    Chandrasekaran Venkataraman
    Apr 21, 2017 at 12:26 pm
    CDSCO should not rest with the findings. It has to take the matter to its logical conclusion and enforcement, just like US FDA, even if it means shutting down the concrned plants of the companies. The action shoud be applicable not only to domestic companies but also multinationls operating in India. It is the Indian citizens who will be affected by such sub-standard drugs, either as patients or through exports.
    Reply
  7. G
    gopal
    Apr 21, 2017 at 11:21 am
    The problem is if the medication does not dissolve in a specific period of time, the undissoved deposits will be formed near kidney and will lead to stone formation. Stringent action is called for medicines that do not dissolve in a reasonable timeframe
    Reply
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