ISLAMABAD: Biological drugs are considered to be the future of medicine but Pakistan lags behind in this form of treatment with the Drug Regulatory Authority of Pakistan (DRAP) failing to register most biological drugs since the last two years.

However, Ministry of National Health Services (NHS) Secretary Ayub Sheikh attributed the delay in registration of these drugs to DRAP’s cautiousness and the shortage of employees, which he claimed would soon be overcome.

Biological drugs are made from living cells such as bacteria and used in prevention and treatment of a number of diseases such as blood disorders, cancer and auto-immune diseases.

Biological drugs include lifesaving products such as blood derivatives, hormones, insulin, vaccines and interferon used by hepatitis patients.

NHS secretary attributes delay to ‘cautiousness’

An NHS ministry official, requesting anonymity, told Dawn that registration of drugs will increase competition in the market and bring down prices.

However, the delay is forcing people suffering from chronic conditions to buy more expensive drugs.

“Most biological drugs cannot be made in Pakistan because of the lengthy research procedure involved so DRAP should expedite the process of registration of imported biological drugs,” he said.

He said: “Globally the biological drug market is growing. According to the Institute for Healthcare Informatics, the global market for these drugs was estimated to be at $161 billion in 2014 and is expected to increase to $287 billion by 2020 at annual growth rate of 10.1 per cent.”

The official explained that across the world, dependence on biological drugs is increasing but such a drug requires more research.

A chemical drug is made after 40 to 50 critical tests but biologic drugs require 250 or more critical tests, he said.

The official said that the expert committee on biological drugs has not held a meeting since 2013.

“Because of delay in registration patients are also deprived of new drugs which have been introduced in international market but not in Pakistan,” he said.

Renowned endocrinologist Dr Osama Ishtiaq told Dawn that biological drugs are made with bacteria and some medicines such as Interferon, Insulin and hormones are available in Pakistan.

“All biological drugs are made in three phases. In the first phase, drugs are tested on animals, in the second phase drugs are tested on both animals and humans and in the third phase, drugs are tested on humans,” he said.

Dr Ishtiaq explained that a biological medicine is introduced in the market after research work of 10 years and the research is published in renowned international journals, so once a drug has been introduced internationally it should be imported in Pakistan. And if a company manufactures the same drug in Pakistan, the tests would have to be repeated.

Meanwhile, an independent regulatory consultant Nadeem Hussain Alamgir told Dawn that registration of biological drugs is a very sensitive issue.

“These drugs are made with bacteria, fungus and virus, which could be very dangerous because of which, these medicines face resistance before being introduced in any country. Since the environment and temperature as well as the food and oxygen levels among people in each country are different, viruses can behave differently,” he said.

Mr Alamgir explained that while chemical drugs only affect the person consuming the medicines, biological drugs can have an impact on future generations as they alter genes and structures of chromosomes.

“I suggest that bio sample studies be conducted in the country before allowing the medicines to be sold in Pakistan, because if a biological medicine is safe in the US it does not mean that it would be safe in Pakistan,” he said.

He cited the strict regulation of biological drugs in other countries and said that in the US biological drugs are registered very carefully even though each company is coming up with new biological drugs as the profits are high. “Similarly in Pakistan, there are some 600 cases pending with DRAP,” he said.

NHS Secretary Ayub Sheikh told Dawn that DRAP is being cautious about registration of biological drugs because of the dangers involved.

“Moreover, we have advertised 192 vacancies which include some for biologists. After appointments are made, registration of these drugs would be expedited,” he said.

Mr Sheikh said that the expert committee on biological drugs has also been expanded.

Published in Dawn, July 23rd, 2015

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