Sunday 5 February 2012

Pharmaceutical sector of Pakistan, GMP compliance, Efroze Pharma and India as MFN (Most Favourite Nation)





In the recent past, Government of Pakistan has decided to declare India as MFN (Most Favourite Nation) i.e,  articles imported from India will be charged minimal or no import duty. Serious concerns over this issue were raised and are still need to be address properly as how the domestic industries will be protected. 




Now read this :
Isotab may have been a  contaminated pill but drug manufacturers say the route from factory’s conveyor  belt to patients’ medicine cabinets is a long one 

Punjab Chief Minister Shahbaz Sharif : a batch of Isotab tablets, meant for heart patients, had been contaminated with an anti-malarial chemical,

Pakistan Pharmaceutical Manufacturers Association (PPMA) claimed:  the real culprit is the lack of a drug regulatory authority. Even if the company manufactured faulty medicine, what were the drug inspectors and the managers at the Punjab Institute of Cardiology doing after the drugs were distributed, he said.
Sindh health secretary, Syed Hashim Raza Zaidi said : As a standard practice, the provincial health department always sends medicines for tests at the laboratory whenever they are bought in large quantities for public sector hospitals.
Cost of panic
Panic over a batch of contaminated medicine threatens to upend a multi-million dollar industry. Economist Arshad Zaman says it poses a serious damage to “Pakistan as a brand” in the global market.
“There are over 400 [pharmaceutical] companies [in Pakistan],” said vice chairman for PPMA Tariq Ikram. “Each company produces an average of 100 products. Millions of units are produced. This is just one company and one product. Such instances happen once in a lifetime and the entire industry’s image should not be damaged because of it,” he said.
The association chairman said contaminated drugs and their recall is a global phenomenon that has affected giants like GlaxoSmithKline and Johnson & Johnson.
Heparin, an anti-coagulant was recalled in March 2008 after a contaminated batch imported from China killed 81 people in the US.
Earlier, Tylenol, a popular American painkiller manufactured by Johnson & Johnson killed seven in 1982 before the product was recalled across the United States.

But panic is spreading fast. The mounting death toll in Punjab and reports from a laboratory in London stating Efroze Pharmaceutical’s IsoTab contained high dosage of anti-malarial pyrimethamine, have led to at least five countries banning cardiology medicines from Pakistan, PPMA says.
Pakistan’s pharmaceutical industry has an estimated worth of $200 million, exports $100 million worth of medicines to over 60 countries, and an annual growth rate of around 30%, said Khawaja.
All that may be on the stake because of a single contaminated batch.
“For decades people have been taking Pakistani medicines and now one dispatch after another is being stopped,” says former PPMA chairman Kaiser Waheed. “The cancellations and bans have started but it will be six months before we can accurately quantify the impact.”
Waheed also defended the company, Efroze Pharmaceutical, which he said has been in the industry for around half a century and exports to 27 countries. “They are a well-known family in the business. They are known as the ‘dawai walas’ because their forefathers were in the business in Calcutta before partition,” he said.

Published in The Express Tribune, February 3rd, 2012.



Editorial of Daily Express February 4, 2012
A really good one



Pharma sector is one of the fast growing sector who is earning foreign exchange for Pakistan for last two decades.  Pharma sector and regulatory authorities of Pakistan were in a debate whether to allow the import of medicine from India or not. ( Although we are already importing APIs (Active Pharmaceutical Ingredients) mainly from China and India.) 

One group is of the opinion that Pharmaceutical Plants in Pakistan, especially National ones are not producing quality medicines which are less effective, therefore, medicines be imported from India which will not only be of superior quality but cost effective too. 

The other group states that if Indian medicines are permitted to import into Pakistan then it would be the last straw on camel's back, as Pharma sector is already facing challenges due to energy crisis as well as apparent corruption in regulatory affairs, and increasing prices of API and excipients. This decision if taken will be a heavy blow for National Pharma as they won't be able to compete the Indian medicines in terms of price, because India do not have to import API and they get subsidies too. This group entrusts the quality of medicine manufactured by Pakistani Pharma.

Here arises a question that whether Pakistani Pharma are capable enough to produce quality medicine, if yes then why Prescribers and health allied professionals dont see eye to eye on the matter of quality medicines.
How we come to know that Medicines and Medicinal Products produced by a particular Pharmaceutical company are of utmost quality or not.

Answer lies in the compliance of GMP (Good Manufacturing Practices)
What is GMP?
GMP is a is a set of practices that gives guidance relating the different aspects of Production and testing that can have a impact on the quality of a product.  Ultimate goals of these guidelines are safeguarding the health of the patient as well as producing good quality medicine, medical devices or active pharmaceutical products. 

Our Drug regulatory authorities are statutorily responsible to make every Pharmaceutical Plant in Pakistan  to operate in compliance with GMP.

In simple words any Pharmaceutical Plant who is certified to be in compliance with GMPs is automatically considered to produce quality medicines

Considering the recent tragedy happened at PIC Lahore, and following the Locking and Sealing of Efroze Chemicals  in Karachi, GMP certified Pharmaceutical Plants are now the need of hour. GMP compliance is the key of prosperity for the Pakistani Pharmaceutical Sector

Who is in compliance with GMP and who is not, I don't know!

I know only that without a qualified pharmacist GMP compliance will remain a dream. Quality has its cost, and for Owners of Pharmaceutical Plants its time to pay this cost!

For those who are blaming  Pakistani Pharmaceutical Plants I must quote someone else words
" We Pharmacist and other people working in Pharmaceutical Plants don't go to Pharmaceutical industry, early in the morning and returns home at night, in order to produce medicines that kill people."

Kamran Zaheer

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