New Delhi: In a major crackdown, 27 commonly sold medicines, which are formulated and labelled under 18 major pharmaceutical brands of India have seem to have failed in quality control. The testing done by drug regulators of seven states including Maharashtra, Karnataka, West Bengal, Goa, Gujarat, Kerala and Andhra Pradesh has revealed these drugs to be substandard.
The citations by the drug controllers alleging the 27 medicines of lacking quality, labeled them as having substandard” quality on grounds of false labeling, wrong quantity of ingredients, discoloration, moisture formation, failing dissolution test and failing disintegration test.
Some of the medicines under scanner are antipsychotic drug Stemetil and antibiotic drug Pentids from Abbott India, anti-bacterial medicine Althrocin by Alembic Pharma, migraine medication Vasograin by Cadila Pharma, popular cough syrup Ascoril by Glenmark Pharma, worm infection drug Zentel by GSK India, arthritis medication Hydroxychloroquine (HCQS) by Ipca Labs, anti-inflammatory medication Myoril by Sanofi Synthelabo, and Torrent Pharma’s hypertension drug Dilzem.
The companies include eight key brands, leaders in their respective molecule categories. The pharma companies sell the same molecule under different brand names, a market share ranging from 47 per cent to 92 per cent.
Brand names as under: Abbott India, GSK India, Sun Pharma, Cipla and Glenmark Pharma, Alkem Labs, Cadila Healthcare, Cipla, Emcure Pharma, Hetero Labs, Morepen Labs, Macleods Pharma, Sun Pharma, Wockhardt Pharma and Zydus Healthcare, Sanofi Synthelabo, and Torrent Pharma’s, Ipca Labs and GSK India.
According to The Indian Express report, two out of these 18 companies have stopped the sale of drugs under scanner of the drug controller, on same line only one pharmaceutical firm said that the affected batch have been reversed back to the company from market.
Citations that the companies made against allegations
On being asked on the matter by The Indian Express, eight companies responded back giving reasons for the laxity and condemning the action by saying that it was not necessary to conduct the tests in this case and that the testing methodology was incorrect and inappropriate. Some of the claims include:
- The companies alleged the drug controllers of seven states that they picked up batches for testing from unofficial distributors, claiming it incorrect. The company was doing contract manufacturing for someone else.
- On the allegations of wrong labeling, the companies said that there was no need for labeling as the picked up drug batches were meant for World Health Organization (WHO).
- The batch was filled with counterfeit medicines.
- They also claimed that there was “inappropriate storage” and “handling” in the marketplace (retailer), which led to quality stoop in medicines.
Some of the quality violations revealed by the respective drug Controllers are as under
- Test conducted by Maharashtra’s drug controller on Alkem Labs medicine.
Time period: August 2016
Drug Name: Clavam Bid syrup (Alkem Labs)
Category: Popular antibiotic
Annual Sale as per AIOCD: Rs 257.32
Conclusion: Drug substandard
Alleged Composition: Clavulanic Acid in excess
- Test conducted by Gujarat’s drug regulator on GSK India’s drug
Time Period: June 2016
Drug Name: Phexin
Category: Commonly sold Antibiotic
Annual Sale as per AIOCD: Rs 71.22 crore.
Alleged Composition: Cephalexin just 63 per cent of the labelled content
Conclusion: Claimed less amount of necessary component, lower than the labeled 63% content. The Drugs and Cosmetics Act, 1940, recommends the content of the active ingredient such as Cephalexin to be not less than 90 per cent.
- Test conducted by Gujarat’s drug regulator on Cadila Healthcare’s medicine
Time Period: April 2016
Drug Name: Amlomed
Category: High blood pressure and Heart disease medicine
Alleged Composition: claimed that the active ingredient was les than hat was labeled in the content
Conclusion: Amlodipine just 53.4 per cent of the “labelled content, which is suppose to be not less than 90 per cent.
- Test conducted by regulators of Karnataka and Maharasthra on Zydus Healthcare’s medicine.
Drug Name: Derisone and Mifegest Kit
Annual Sale as per AIOCD: Rs 116.6 crore
- Test conducted by Karnataka’s drug regulator onCadila Pharma medicine
Time period: September 2016
Drug Name: Polycap
Category: Heart disease medicine (Preventive)
- Test conducted by Gujarat’s drug regulator on Cadila Pharma’s medicine
Drug Name: Symbiotik
Category: Respiratory tract infections
- Tests conducted by drug regulators of West Bengal, Andhra Pradesh, Gujarat and Kerela respectively on Cipla’s four different medicines
Drug Name: Fixobact, Ciploric, Omecip D and Dilvas
- Test conducted by Gujarat’s drug regulator on Emcure Pharma’s medicine
Time Period: August 2016
Drug Name: Rifampin
Conclusion: Lumps formation of the contents of the vials
- Test conducted by Drug regulators of West Bengal and Maharashtraon Two drugs of Hetero Labs
Drug Name: Rablet and Plavas
- Test conducted by West Bengal’s drug regulator on Morepen Labs and Macleod Pharma’s
Drug Name: Rabiwok (Morepen Labs) and Entroflora (Macleod Pharma)
Conclusion: low quality
- Test conducted by Karnataka’s drug regulator on Sun Pharma’s medicine
Time Period: August this year
Drug Name: Ferinca
Category: Treat iron or folic acid deficiency
Annual Sale as per AIOCD: Rs 80 lakh.
Conclusion: Failed the disintegration test
- Test conducted by Maharashtra’s drug regulator on Wockhardt Pharma’s drug
Time Period: April 2016
Drug Name: Enpril
Category: High blood pressure medicine
Conclusion: Failed the dissolution