Updated: November 28, 2016 4:30:53 pm
In a major crackdown since March this year, the drug regulators of seven states have alleged that 27 medicines — sold by 18 major drug companies in India including Abbott India, GSK India, Sun Pharma, Cipla and Glenmark Pharma — are of “substandard” quality, citing grounds such as false labelling, wrong quantity of ingredients, discolouration, moisture formation, failing dissolution test and failing disintegration test.
WATCH VIDEO: Find Out Which 27 Medicines ‘Failed’ Quality Test
These include key drug brands of eight top-tier companies, which are the leaders in their respective molecule categories (pharma companies sell the same molecule under different brand names) with a market share ranging from 47 per cent to 92 per cent. Of the 18 companies, only two said they had stopped sale of the affected drug batches and just one said the affected batch had been recalled from the market.
Some of the key brands which were alleged to be substandard 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.
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The tests on the 27 medicines were done by drug regulators of Maharashtra, Karnataka, West Bengal, Goa, Gujarat, Kerala and Andhra Pradesh. The 10 other companies that were alleged to be selling substandard drugs are Alkem Labs, Cadila Healthcare, Cipla, Emcure Pharma, Hetero Labs, Morepen Labs, Macleods Pharma, Sun Pharma, Wockhardt Pharma and Zydus Healthcare.
Only eight companies responded to specific queries sent by The Indian Express on the findings of the regulators. Among the reasons they cited were: drug batches were picked up for testing from an “unofficial distributor”; no “labelling requirement” as drug batch was meant for the World Health Organisation; a batch of “counterfeit” drugs were picked up for testing; test conducted on the drug was “not necessary”; testing methodology “incorrect”; the company was doing contract manufacturing for someone else; “inappropriate storage” and “handling” in the marketplace (retailer).
Some of the drugs under the scanner:
1. In August this year, Maharashtra’s drug controller claimed Alkem Labs’ popular antibiotic, Clavam Bid syrup, was substandard as it contained excess amount of Clavulanic Acid. According to the All Indian Origin Chemists & Distributors (AIOCD) data for September, this medicine had annual sales of Rs 257.32 crore in India.
2. GSK India’s Phexin, an antibiotic used to treat respiratory infections, has Cephalexin as its main ingredient. Gujarat’s drug regulator, in its tests done in June this year, claimed Cephalexin to be just 63 per cent of the labelled content. As per the Drugs and Cosmetics Act, 1940, the content of the active ingredient such as Cephalexin must not be less than 90 per cent. According to AIOCD data, Phexin had annual sales of Rs 71.22 crore.
3. Cadila Healthcare’s Amlomed, which is used to treat high blood pressure and heart disease, was twice alleged to be substandard by Gujarat’s drug regulator in April. Amlodipine is the main ingredient of Amlomed. The regulator claimed that Amlodipine was just 53.4 per cent of the “labelled content”; the content of active ingredient such as Amlodipine cannot be less than 90 per cent.
4. Zydus Healthcare’s Derisone and Mifegest Kit were alleged to be substandard by the drug regulators of Karnataka and Maharasthra. According to AIOCD, Mifegest Kit had an annual sales of Rs 116.6 crore. Both the companies, Cadila Healthcare and Zydus Healthcare, are part of the Pankaj Patel-led Zydus Cadila group.
5. Polycap, a five-in-one pill by the Rajiv Modi-led Cadila Pharma which is used to prevent heart disease, was alleged to be substandard by Karnataka’s drug regulator in September. Cadila Pharma’s Symbiotik, which is used to treat respiratory tract infections, was also alleged to be substandard by Gujarat’s drug regulator.
6. Cipla’s four different medicines — Fixobact, Ciploric, Omecip D and Dilvas — were alleged to be substandard by the drug regulators of West Bengal, Andhra Pradesh, Gujarat and Kerela respectively.
7. Gujarat’s drug regulator, which claimed Emcure Pharma’s antibiotic drug Rifampin was substandard in August, said in its report: “Almost all vials received for analysis show lumps formation of the contents of the vials.”
8. Two drugs of Hetero Labs — Rablet and Plavas — were alleged to be substandard by the drug regulators of West Bengal and Maharashtra respectively.
9. Morepen Labs’ Rabiwok and Macleod Pharma’s Entroflora were alleged to be of low quality by West Bengal’s drug regulator.
10. Sun Pharma’s Ferinca, used to treat iron or folic acid deficiency, reportedly failed the disintegration test of Karnataka’s drug regulator in August this year. According to AIOCD, Ferinca had an annual sales of Rs 80 lakh.
11. Wockhardt Pharma’s Enpril, a high blood pressure medicine, reportedly failed the dissolution test of Maharashtra’s drug regulator in April this year. Dissolution test checks the time taken by the medicine to dissolve in the blood stream. Disintegration test checks the time taken by the drug to break down into pieces in the blood stream. Disintegration is a subset of dissolution.
WHAT THE PHARMA COMPANIES SAID
Pentids-400: Abbott received information from the Kerala drug controller in May 2016 about some tablets of Pentids-400 being discoloured and having moisture. Testing performed for a portion of the collected samples by a government laboratory confirmed that the product met all specifications. Control samples and batch records of the same batch were also found satisfactory, and we have not received any other complaints from this batch. This isolated event was caused by inappropriate storage and handling in the marketplace. We have shared these details with the state drug authorities, explaining why there was no need to recall the said batch.
Stemetil-MD: Abbott received a query from the West Bengal drug control authorities, asking us to establish the authenticity of a sample from this batch. Upon review, we found that the sample submitted was not genuine Abbott product. The details of the manufacturing date, the brand name artwork on the pack, the printing on the pack and alignment were inconsistent with our original pack design and control samples. Abbott immediately notified the drug control authorities in West Bengal and the state of manufacture (Himachal Pradesh).
Ascoril: The batch numbers mentioned in the report are not manufactured or marketed by Glenmark. We have responded to the showcause notice and informed the relevant authority accordingly.
Phexin Redisyp: Regarding the notice from Gujarat FDA, we do not agree with the said report and have challenged the same on the ground that the government analyst did not use the correct methodology whilst testing and analysing the sample. We have filed an application before the magistrate’s court at Surendernagar for retesting of the sample by Central Drugs Laboratory (CDL). The sample has been sent to CDL by the court and the report is awaited.
Zentel: With regard to… the notice from West Bengal FDA regarding compliance of labeling requirements as per the Drugs & Cosmetics Rules for the supplies made to WHO… the supplies were exclusively for a programme run by WHO in association with the government of India. DCGI has already issued a letter exempting us from the labeling requirements for such supplies and the same has been communicated to West Bengal FDA.
Myoril: The sample in question was picked up from a location which is not in our official list of distribution. Hence, the authenticity and storage conditions of the sample cannot be ascertained. There is no issue with quality of our product.
Ferinca: According to the samples tested by the state regulator, Ferinca was reported as failing in disintegration test. Sun Pharma has successfully conducted dissolution tests instead of disintegration test on Ferinca. According to Indian Pharmacopoeia, where a dissolution test is prescribed, a disintegration test is not necessary. Ferinca is a quality pharmaceutical product and complies with our in-house specifications. We have already sent a clarification to the state regulator on this matter.
Rabiwok: The drug in question… is not marketed by us, we have done contract manufacturing on behalf of Wockhardt. We are not allowed to interact directly with any customer. We have written to the marketeer (Wockhardt) in this regard (drug recall). We have tested the control sample, The drug has been found satisfactory in all parameters, the assay is as per prescribed the standard by the drug controller, which is around 90 per cent.
Polycap, Symbiotik and Vasograin: Cadila Pharma acknowledges the complaints received from the FDA office. We have immediately honoured the call given by the agency to hold further sale of the said batch numbers and have requested the FDA office for a personal hearing to discuss the matter. We are now awaiting further directives from FDA. Meanwhile, we have also re-tested the samples from the same batches internally and found them to be all right.
Entroflora: Based on the intimation and report we received from Maharashtra’s Drug Controller about Entroflora, we immediately recalled the batch from the market. Our formulation and R&D team was given the task to thoroughly investigate and analyse the raw material, excipients, manufacturing process and post-manufacturing stability to find out the reason and to devise the corrective action… The suggested course correction was immediately implemented from next batch and available products in the market are of standard quality.
Alkem Labs, Cadila Healthcare, Cipla, Emcure Pharma, Hetero Labs, Wockhardt Pharma, Zydus Healthcare, Ipca Labs, Alembic Pharma and Torrent Pharma did not respond to queries.
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