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The Bitter Pill of Regulations: Hindering Innovation in Pakistan's Pharma Industry

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PIDE Official

PIDE Official

Ай бұрын

Pakistan has been facing persistent drug shortages since the beginning of its creation, when there was no pharmaceutical industry and all the drugs had to be imported. In other words, drug shortages is not a new or recent phenomenon. However, even now, when the pharmaceutical industry consists of 750 (or near about) firms, including two dozen MNCs, shortages of life-saving medicines are still a regularly occurring phenomenon. Recently, the shortage of Insulin and other life-saving drugs has been highlighted in the news.
Put simply, these shortages put lives at risk. This has been demonstrated/reported ample number of times. Besides the threat to lives, the shortages have a huge monetary and economic cost. Last year, in a first, an M.Phil thesis at PIDE calculated the monetary losses due to shortages to be at least Rs. 80 million (approximately). As stated, this has economy-wide repercussions too. For example, the current head of the World Bank, Kristalina Georgieva, calculated that a healthy workforce increases the GDP annually by 1.5 percent per year, implying that a healthy labor force brings its own positive economic spillovers. A healthy labor force, in turn, cannot be had in absence of availability of quality drugs and Medicare. Conversely, Remes et.al calculated that poor health around the globe causes significant reduction in potential GDP growth.[4]
In essence, not only do drug shortages put lives at risk, but they also have significant economic repercussions.
Government’s failure at addressing the issue
So what is the way forward? The following lines propose several solutions, based on the author’s understanding of the issue and complementing research.
Government’s regulatory role should be concentrated upon quality assurance, discouraging hoarding and checking unethical practices (false branding/misbranding, marketing same formulation drugs at higher prices by changing the brand name, etc.). The practice of fix drug prices, especially the process of Cabinet’s approval for price increases, should be done away with completely. The pricing issue should not go beyond the regulator, DRAP, to whom firms already submit details like costs of production, and which can negotiate pricing based on agreed upon criterion like reference pricing or costs of energy, which directly feed into overall costs of production
There should be continuity of policies once they are approved, without any injunction for SROs or court orders. Once a policy is approved in consultation with the industry (including both PPMA and PB), the Cabinet should have no role to play in it
In case of any dispute arising in terms of pricing, there should be an Appellate Panel consisting of eminent specialists in the field, who would adjudge the dispute within a month. Otherwise, disputes remain stuck in courts for years without any resolution.
As an incentive to produce cheaper versions of innovator brands at home, the insurance coverage for drugs should cover only generics and branded generics produced within the country.
There should be no bar upon domestic firms entering into agreements with foreign companies in terms of production of drugs, either for export purposes or for domestic sales. If a foreign company of repute is satisfied with the production facilities of a domestic company and agrees joint production/outsourcing production of a drug, the domestic company should not require any NOC from DRAP for production of that drug
#Pakistan #PharmaIndustry #Medicines #Drugs #DrugRegulations #Regulations #DRAP #FDA #LifeSaving #Health #Budget #Budget2024 #DrugShortage
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Пікірлер: 20
@Dr.ArbazRahmann
@Dr.ArbazRahmann Ай бұрын
I totally disagree with the speaker that Pakistani pharma colonies import low quality APIs from China or India. APIs imported from China or India are of international standards and it is our Pharma companies who mix low quality salts and therefore low quality drugs.
@shahidmehmood1477
@shahidmehmood1477 Ай бұрын
Get you info updated my friend- Pakistan does not import high quality APIs because they are expensive and would need to be sold at very high prices which is not allowed in Pakistan. Sit with PPMA and DRAP to learn the difference
@Dr.ArbazRahmann
@Dr.ArbazRahmann Ай бұрын
Mashallah very good and informative podcast by PIDE and I never miss Dr. Nadeem’s talk. Dr. Nadeem ul Haq took few seconds to explain difference between branded drug and generic drug but the speaker could not despite so much knowledge about pharmaceuticals. There is a thing called Patent and buying patents before the patent expired after specified time. Not a single company in Pakistan has developed patented drug in 75 years. Everyone talks about generic drugs being manufactured in India but no one talks about how much research in India is done and how many patents Indian companies have developed.
@GuzzarAwan
@GuzzarAwan Ай бұрын
Indian company SERUM institute (world biggest Vaccine maker) and Bharat Biotech now r developing lot of Newer vaccines for various disease which have been aproved by WHO too. Pakistanis prolly don't know but in India Biotech engineering is also very good like IT.
@shahidmehmood1477
@shahidmehmood1477 Ай бұрын
Sahi, please explain what's the difference between Generics and Branded drugs?
@DrAahad-xo6ev
@DrAahad-xo6ev Ай бұрын
Regulaton for supermacy and sepages not for standardization purposes. Every activity needs permit, warehouse, civil defence, severage licience, drain licience etc. Lab do not 've analytical standard for label quality standard.
@shoaibaijaz2856
@shoaibaijaz2856 Ай бұрын
Another major challenge for the pharmaceutical industry is inflation. Recently, companies have been cutting down on their products instead of focusing on innovation because they can't match their competitors' prices.
@shoaibaijaz2856
@shoaibaijaz2856 Ай бұрын
Registering new medicines in Pakistan is challenging. The process takes around 1.7 years and requires 28 visits, costing the overall GDP about 0.03%. This involves more than 3 to 4 regulatory bodies. (Source: PIDE Sludge Audit 2)
@shoaibaijaz2856
@shoaibaijaz2856 Ай бұрын
Well explained Dr. Sahab the issues facing the pharmaceutical industry in Pakistan. Prices are controlled by the government rather than being set by the market. Due to high inflation, the government increase prices but not drug prices. It's impossible to buy anything for one rupee, let alone sell drugs like Panadol for that amount. Because the government sets the prices, investors aren't interested in charity. Consequently, they close the supply chain, leading to drug shortages and black market sales.
@1979jlr
@1979jlr Ай бұрын
Indias 🇮🇳 pharmacy business stood at over USD 50 billion for the 2022-23. On average, India exports pharma products worth USD 2-3 billion every month. India's pharmaceutical industry is the third largest by volume and the 13th largest by value in the world, producing more than 60,000 generic drugs across 60 therapeutic categories.24 Apr 2024
@shoaibaijaz2856
@shoaibaijaz2856 Ай бұрын
Pharmaceutical investors also don't want to deal with Regulators due to trade perspectives. They are advocating for an open market, but here, obtaining permission is a challenge. Pharma investors must always get approval from Regulator's As PIDE (Pakistan Institute of Development Economics) has shown, these permissions take time, often resulting in order cancellations. If drugs are not supplied to patients on time, they cannot effectively solve patients' problems. But in Pakistan permission 1st.
@muhammadjunaid3773
@muhammadjunaid3773 Ай бұрын
Informative... Imports of APIs costs less than production at home. Further as per PBC and CDPR report on potential of Pharma it is highly skewed income based industry where top 50 firms makes 97% of income and other 700 compete for 3%. Further among the 17 MNCs only 7 are actively producing drugs others are only producing neutraceuticals...
@divyanshsh
@divyanshsh Ай бұрын
need online retailer direct from manufacturer, if you cannot do that, then only options is to buy from India
@DrAahad-xo6ev
@DrAahad-xo6ev Ай бұрын
Iss region me sub choawr he chowr koe big ya koe minor chwor.
@advocatehafiznasirmahmood5980
@advocatehafiznasirmahmood5980 Ай бұрын
Very beautiful ❤
@GuzzarAwan
@GuzzarAwan Ай бұрын
Competing with India in pharma is almost impossible for pakistan . Pakistan thinks it can replicate indian model of IT and pharma . But reality is india has very strong foundation of Computer science and Biotech engineering in its colleges . Both were laid during 1990s after leaders understood its importance. India missed semiconductor and wirless so it lost the race. Today if india tries to replicate china in these 2 sector or even in overall manufacturing, it will never able to match china level. But geopolitics is helping india and West is helping india in these two sectors . But india will need another 3 decades even after help from west to match chinas capability. In 1980s West had decided to give Role of factory to china. In 1990s break of Ussr they decided to give role of BACKOFFICE IT services to india . India also carved out sector of generic Pharma factory of the world , western Pharma first hindered later allowed . Indian pharma had huge role in helping Africa. Now india is also mastering vaccines development and production. Quality of many companies have also improved to Western stabdards as US FDA was allowed to vet and raid regularly their indian facrories. This helped many companies to improve and get FDA certificates. What was the role given to pakistan or taken by it ?? Well it was given the role of Proxy warfare , frontline state etc though even there it backstabbed west. So overall no nation can match pakistan in proxy warfare today. Now Pakistan after waking up for first time that real power is economy and industrial capacity tried to find what it can target. It found its children r freelancing due to internet . Finally they named it IT exports and claimed it as govt success . Reality is India is moving from Backoffice of IT which is now moving to AI . To GLOBAL CAPABILITY CENTRE. Pakistanis shd find out what GCC are and how many GCC recently have been invested in india last year. India will never be able to match china as factory of the world. That time and era has passed now . India will carve new path , play on its strength i.e. services . Pakistan shd understand this is globalised world nation which will try to remain closed securitised will be erased one day or other . Pakistan have woke up recently and r looking for solution in 1990s when world has moved to 2024. Such small marketoke pakistan can never able to sustain good efficient Pharama company which can match India. Better close them and focus ur resources on better sectors where u can be champion in world market .
@SulemanAbbas-jp3im
@SulemanAbbas-jp3im Ай бұрын
guest identified nuances instead of scholarly knowledge, quite disapponting
@shahidmehmood1477
@shahidmehmood1477 Ай бұрын
Podcasts for consumption of general public who don't understand technicalities and wouldn't even listen to it. So one has to discuss, mostly, generalities
@ashwwal3409
@ashwwal3409 Ай бұрын
India bana raha hai , export kar raha hai , hum kyu nahi kar rahe hai . The main reason is your emaan and jazba .
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