Low-Quality Drug Production: Ban stays on 20 drug companies
The High Court yesterday upheld its earlier order that directed the government to stop the production of 20 pharmaceutical companies for producing substandard drugs.
It also directed the government to take necessary step so that 14 other pharmaceutical companies cannot produce antibiotics, as those were also below par.
Delivering the verdict on a writ petition, the HC asked the director general of the Directorate General of Drug Administration (DGDA) to monitor the activities of drug companies, see that the orders are implemented, and report to the court every three months.
The HC also formed a five-member committee to examine the products of three drug companies that have been banned from producing drugs yesterday but claim to have received Good Manufacturing Practice (GMP) recommendation from the World Health Organisation (WHO).
Ad Din Pharmaceuticals Ltd, Avert Pharma Ltd and MST Pharmaceuticals Ltd are the three companies.
The committee is comprised of a representative each from the WHO, the health ministry, department of pharmacy of Dhaka University, the DGDA, and an expert committee formed earlier by parliament.
Based on the recommendations of the committee, the authorities concerned would decide whether the three companies would be able to produce drugs, the court added.
The HC bench of Justice Syed Muhammad Dastagir Husain and Justice Md Ataur Rahman Khan came up with the verdict after holding a hearing on the writ petition of Human Rights and Peace for Bangladesh (HRPB) filed on June 5.
In the petition, the rights organisation sought HC directive on the government to cancel licences of 20 pharmaceutical companies and stop their production.
It also prayed for action against the 14 companies who were making substandard antibiotics.
CASE PROCEEDING
An expert committee was formed with the permission of the speaker of the Jatiya Sangsad following allegations that several companies were producing drug without complying with the GMP policy of the WHO.
After visiting 84 pharmaceutical companies, the committee recommended that the government cancel licences of 20 companies and stop the production of antibiotics of 14 other companies.
On June 5 last year, HRPB filed the writ petition after media reports said the authorities concerned did not take action as per the committee's recommendations.
The petition said the right to life of citizens was being violated due to manufacturing of substandard medicines.
On August 8, the HC ordered the government to stop all drug production of 20 pharmaceutical companies and production of antibiotics of 14 others and withdraw their products from the market.
It had also issued a rule upon the authorities concerned to explain why licences of the companies should not be ordered to be cancelled.
But some of those companies went to the Appellate Division seeking a stay on the HC order. The Appellate Division denied them the stay order. The Appellate Division also directed the HC bench to hold hearing on the rule it had issued.
Yesterday, the HC delivered the verdict after holding a hearing on the rule.
Writ petitioner's counsel Manzill Murshid told The Daily Star that every drug company must produce standard medicines under the GMP policy of the WHO, as per Section 15(1) of Drug (Control) Ordinance, 1982.
If the drug companies do not abide by this provision, their licences would be cancelled or suspended, he said, adding that a person could be sentenced for up to five years in prison for producing substandard drugs.
Manzill also said the 34 drug companies had produced medicines without following the provision of the law and were helped by the inaction of the authorities concerned.
The 20 drug companies that have been banned from producing drugs are: Aexim Pharmaceuticals Ltd, Avert Pharma Ltd, Bikolpo Pharmaceuticals Ltd, Dolphin Pharmaceuticals Ltd, Drugland Ltd, Globe Laboratories (pvt) Ltd, Jalpha Laboratories Ltd, Kafma Pharmaceuticals Ltd, Medico Pharmaceuticals Ltd, National Drug Pharma Ltd, North Bengal Pharmaceuticals Ltd, Remo Chemicals Ltd (Pharma Division), Rid Pharmaceuticals Ltd, Skylab Pharmaceuticals Ltd, Spark Pharmaceuticals Ltd, Star Pharmaceuticals Ltd, Sunipun Pharmaceuticals Ltd, Today Pharmaceuticals Ltd, Tropical Pharmaceuticals Ltd, and Universal Pharmaceuticals Ltd.
The 14 companies that have been banned from manufacturing antibiotics are: Ad Din Pharmaceuticals Ltd, Alkad Pharmaceuticals Ltd, Belsen Pharmaceuticals Ltd, Bengal Drugs Pharmaceuticals Ltd, Bistol Pharmaceuticals Ltd, Crystal Pharmaceuticals Ltd, Indo Bangla Pharmaceuticals Ltd, Millat Pharmaceuticals Ltd, MST Pharmaceuticals Ltd, Orbit Pharmaceuticals Ltd, Pharmatik Pharmaceuticals Ltd, Phoenix Pharmaceuticals Ltd, Rasa Pharmaceuticals Ltd and Save Pharmaceuticals Ltd.