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New law on medicine regulation on the cards

  • Published at 11:20 pm November 13th, 2020
Drug Medicine Tablets
Used blister packets that contained medicines, tablets and pills are seen, in this picture illustration taken on June 30, 2018 Reuters

Life term for drug malpractice likely

The government has been working on introducing a fresh law soon with tougher punishments, including life-term imprisonment to prevent malpractice by producing, storing and selling counterfeit or adulterated medicines.

The new draft “Drug Act 2019” is now undergoing some last minute corrections at the Ministry of Health and Family Welfare following consultations with government organizations and stakeholders, sources said.

The bill, written in Bangla, is being prepared by merging and updating the Drug Act 1940 and Drug (control) Ordinance, 1982.

The 1940 act and the 1982 ordinance focus on drug quality. The 1940 act does not say anything about drug adulteration.

The National Drug Policy 2016 had suggested the fresh law as existing policies, laws, and relevant rules had become insufficient and unable to control and monitor different systems of medicine manufacturing, quality-control, sale, distribution, storage, import, and export.

The maximum punishment under the Drug (control) Ordinance, 1982 is currently 10 years of imprisonment.

The envisaged law will have revised and increased punishment for some other offences to make it more stringent than the existing law.

Very few instances of punishment

Surprisingly, examples of awarding 10-year rigorous jail terms by the court for drug adulteration in Bangladesh are very few so far.

The first one was awarded in July, 2014 to an owner and two officials of Adflame Pharmaceuticals in a case filed over the deaths of 76 children from adulterated drugs in the 1990’s. In the next year six BCI Pharmaceuticals officials faced the same punishment.

However, an official of Polychem Laboratories Limited was jailed for only one year in 2019 following a prolonged legal battle for 26 years.

The BCI, Adflame Pharmaceuticals, Polychem Laboratories, and Rex Pharma reportedly used industrial toxic chemical Di-Ethylene Glycol in their respective brands of paracetamol.

In November 2016, the court acquitted all five officials of Rid Pharmaceuticals Ltd in a case filed for manufacturing toxic paracetamol syrup that killed 28 children across Bangladesh in 2009.

What the authorities say

The government earlier asked the Directorate General of Drug Administration (DGDA) to come up with a draft. It prepared the draft copy with proposals and sent it to the ministry. Dhaka Tribune has acquired a copy of the draft.

Responding to Dhaka Tribune’s query, DGDA Director Major General Md Mahbubur Rahman confirmed that the directorate general had sent the draft copy to the Health Ministry to be placed before the cabinet for approval.

“This law is very important for the drug sector. We have merged contents from the existing ordinance, the act, and added some new sections to make this law up-to-date. Before drafting this law we got opinions from all of our stakeholders. Now we are waiting for its approval,” he said.

The Secretary of the Health Services Division of the Health Ministry, Md Abdul Mannan, said: “This law is badly needed to make our drug and health sector more accountable.”

A top-level source at the Health Ministry said the draft was sent to the Cabinet Division earlier and it sent it back four times suggesting some corrections. The corrections have been made and they are waiting for the division’s final nod.

Also Read - Toxic paracetamol: 26yrs after case, Polychem director gets 1yr jail

The official also claimed that there are some vested quarters from the medicine manufacturers who did not want this law. They tried to make this approval lengthy. “Actually, this law making process has been ongoing since 2013. But now we are at the final stage,” he said.

Wishing to remain anonymous, another official at the ministry said tougher punishment was recommended in the new draft to instil fear among offenders. 

There were instances of lighter punishment for manufacturing and selling adulterated medicine that caused children to die. It sent a message among the victims that they have been denied proper justice, he said.

Besides, in the future the government may consider forming special tribunals for speedy trial of drug cases. Tightening the law is a step towards that.

Offenders to get life imprisonment

According to the new draft, if any person adulterates any drug knowingly or deliberately, he will be sentenced to life imprisonment or not more than 14 years in jail and a fine of Tk20 lakhs. The same punishment goes for offenders who store, sell, distribute, or showcase the same.

For producing falsified or counterfeit drugs and storing, selling, distributing or showcasing, the offenders will be sentenced to life-term imprisonment or a jail term of maximum 14 years and a fine of Tk20 lakhs.

At present the maximum punishment for these offences are 10 years in jail and a fine of Tk2 lakhs.

Selling unregistered or substandard drug punishable offence

If any person, company or medicine shops manufacture, import, store, distribute, showcase and sell any kind of unregistered medicine they will be awarded ten years in prison and Tk10 lakh fine under the new law.

The same punishment is applicable for producing and importing drugs without a proper license. 

The draft law also recommended punishment for hawking any kind of allopathic, unani, Ayurvedic, homeopathic, Biochemic, herbal or any other medicine at footpaths, highways, parks, or mass transport. The offenders will be sentenced up to two-year imprisonment and Tk2 lakhs fine.

If any person or company produces, stores or sells substandard medicine they will be awarded to seven years behind the bars and Tk10 lakhs fine, which is currently five years’ imprisonment and Tk1 lakh fine. 

No selling online 

Without a proper license nobody will be allowed to sell, store, showcase or distribute any kind of medicine online. No website or online platform can be used for this purpose as well. 

The offenders will get five years in prison and a fine of Tk5 lakhs maximum.

Expired medicines, physicians’ samples not for sale

The drug stores will have to be more cautious about out of date medicines as it might cost them three years in prison and a fine of Tk3 lakhs. 

Besides, without doctors’ prescription, the pharmacies will only be allowed to sell over-the-counter (OTC) medicines, otherwise known as non-prescription medicines.

All antimicrobial drugs that include antibiotics, antifungals, antiprotozoals, and antivirals can be sold only with a registered physicians’ prescription. Otherwise shopkeepers will have to pay Tk20,000 as penalty.

Besides, no sellers will be allowed to store, showcase or sell free samples of drugs meant for the physicians, a fine of Tk20,000 will be applicable otherwise.

No import-export without approval

Under the law nobody will be allowed to import any foreign medicine, ingredients to manufacture medicine or drugs’ packaging materials. The offender will be sentenced to up to three years in prison and a fine of Tk3 lakhs.

Besides, even with proper approval, if importers import drugs at a higher price than the government’s approved rate, they will be awarded Tk2 lakhs fine and two years in prison. For illegal export, punishment is Tk1 lakh.

No misleading advertisement

No one will be allowed to publish or participate in any advertisement that contains information of the effectiveness of particular medicines and in default offenders will be awarded maximum five years imprisonment and a fine of Tk5 lakhs.

Misappropriating government medicines

If anybody steals or sells government medicines meant for free distribution among patients from any storage, hospitals, clinics, health centres, and stores, he will be sentenced to a maximum of 10 years of imprisonment and clamped a fine of Tk10 lakh.

Liabilities of drug companies

The recommended law says that if any medicine manufacturing company, corporation, or organization commits any offense which is punishable under the law everyone involved or informed -- the owner, directors, partners, and officers – will be punished.

Repeated offenses committed under any section of the law are punishable with the same kind of sentences.