Medicines are a boon to humanity as they cure many diseases. They have been a consistent companion of man since ages. With the advent of technology and our understanding of biochemistry, the use of synthetic compounds has increased dramatically, which has also increased associated toxicity of the medicines.
The drug regulators of seven states in the country have alleged that almost 18 major pharmaceutical companies in India are selling substandard quality of medicines. Major companies like Abbott India, GSK India, Sun Pharma, Glenmark Pharma, Cipla are accused on the grounds of false labelling, discolouration, wrong quality of ingredients, failing dissolution test, moisture formation and also failing the disintegration test.
Out of 18 companies, only two have agreed to stop sales of the affected drug batches, and others claimed that they have recalled the medicines from the market.
Some of the key brands of eight top-tier companies are Althrocin by Alembic Pharma, Antipsychotic drug Stemetil, antibiotic drug Pentids from Abbott India, migraine medication vasograin by Cadila Pharma, Ascoril by Glenmark Pharma, Zentel by GSK India, arthritis medicine Hydroxychloroquine (HCQS) by Ipca Labs, anti-inflammatory medication Myoril by Sanofi Synthelabo and Hypertension drug Dilzem by Torrent Pharma.
The quality test was done on 27 medicines by drug regulators of Karnataka, Maharashtra, Goa, West Bengal, Andhra Pradesh and Kerala. Ten companies were alleged to be selling non-standard drugs which include Cadila Healthcare, Alkem Labs, Hetero Labs, Encure Pharma, Macleods Pharma, Morepen Labs, Wockhardt Pharma, Sun Pharma and Zydus Healthcare.
Eight companies responded to the queries on the finding of regulators, as reported by The Indian Express. The reasons cited were that the drug batches were picked up for checking from an unofficial distributor, labelling requirement was necessary as the pharmaceutical batch was supposed to be dispatched to World Health Organization.
The drugs under scanner are:
- Clavam Bid syrup, the popular antibiotic of Alkem Lab was claimed to be the substandard by Maharashtra’s drug controller as it had the excess amount of Clavulanic Acid. The excess consumption of this acid results in abdominal cramps, swelling of feet, bleeding gums, tarry stools, chest pain, etc.
- GSK India’s Phexin is used to treat respiratory infections has Cephalexin. Gujarat’s drug regulator claimed that cephalexin had only 63 percent of the labelled content while the substance of this active ingredient should not be less than 90 percent.
- Amolmed by Cadila Healthcare is used to treat high blood pressure and heart disease. The main ingredient of this drug is Amlodipine which was just 53.4 percent of the labelled content and the content of the active ingredient should not be less than 90 percent.
- Cipla’s medicines – Ciploric, Fixobact, Dilvas, Omecip D were alleged to be substandard by the drug regulators of West Bengal, Andhra Pradesh, Gujarat and Kerala.
The other drugs under the scanner were Polycap by Cadila Pharma, Rifampin by Emcure Ciploric, Rablet and Palvas by Hetero Labs, Rabiwok by Morpen labs, Entroflora by Macleod, Fernica by Sun Pharma and Enpril by Wockhardt Pharma.
More information about this can be found here.