Tag Archives: cold

Covid-19 Vaccines – A Multifaceted Perspective

Posted on by
Reply

Even after the destruction of millions of lives, livelihoods, social fabric and national economy of almost all countries – the mayhem of the Coronavirus pandemic continues, unabated.

Echoing what many other global experts, the United States National Institute of Allergy and Infectious Diseases Director has also reiterated ‘that the only “ultimate solution” for the Coronavirus would be a vaccine.’ He added, the social distancing measures and travel restrictions could help curb the outbreak but can’t last forever. Moreover, the virus might come back. Thus, only a vaccine could help in the long run.

That a speedy progress in achieving this goal, is the most critical remits for the global medical scientists and technologists, attract not many contrarian viewpoints. Nevertheless, some red flags are also visible in this critical area. Thus, to give a multifaceted perspective to the ‘Covid-19 vaccine story’, let me dwell on some of these contentious areas.

Vaccines may not be ‘silver bullets’ for all:

According to the news release of the World Health Organization (W.H.O) on July 15, 2020, 75 countries have submitted expressions of interest to protect their populations and those of other nations through joining the COVAX Facility. This is a mechanism designed to guarantee rapid, fair and equitable access to COVID-19 vaccines worldwide. These countries would finance the vaccines from their own public finance budgets and partner with up to 90 lower-income countries.

It further added, interest from governments representing more than 60 percent of the world’s population offers ‘tremendous vote of confidence’ in the effort to ensure truly global access to COVID-19 vaccines, once developed.

Expressing its optimism and also a concern at the same time, the W.H.O on August 03, 2020, informed – out of a number of vaccines, which are now in phase-3 clinical trials, it hopes to have a number of effective vaccines that can help prevent people from infection. Interestingly, in the same breath, it cautioned, “there’s no silver bullet at the moment and there might never be.” The question, that may arise, if a ‘silver bullet’ in the form of Covid-19 vaccines is not available and a vaccine doesn’t work for all, how complicated would then the situation be? Can one expect Covid-19 to end, at all?

When can one expect Covid-19 to end, if at all?

Closely following the above message – “there’s no silver bullet at the moment and there might never be,” another message, a bit intriguing, though, came from the W.H.O on August 22, 2020. This time the W.H.O said, “it hopes the planet will be rid of the Coronavirus pandemic in less than two years — faster than it took for the Spanish flu.” Elaborating the point, the W.H.O Chief underscored, by “utilizing the available tools to the maximum and hoping that we can have additional tools like vaccines, I think we can finish it in a shorter time than the 1918 flu.”

The impact of anti-vaccine movement to end Coronavirus pandemic: 

The question may sound crazy to many people, especially in India, but a similar concern has been expressed by many experts. The article – ‘Anti-vaccine movement could undermine efforts to end Coronavirus pandemic, researchers warn,’ published by the Nature on May 13, 2020, also raised this issue. The researchers of the study at the George Washington University, wrote - ‘studies of social networks show that opposition to vaccines is small but far-reaching — and growing.’

That anti-vaccine sentiments continue growing online, as medical scientists are flooring the gas pedal, has also been reported by ‘India Today’ on May 28, 2020 in an article titled, ‘Experimental Covid shots inject anti-vaccine sentiments.’ This belief was ‘prompted by theories that fast-tracked programs are profit-driven, loaded with health risks and will eventually lead to enforced immunization,’ it underscored. Notably, the W.H.O also has flagged the growing anti-vaccine feeling.

W.H.O flagged the growing anti-vaccine feeling:

The issue of growing anti-vaccine feeling has also been flagged by the W.H.O. It noted several reasons for fear of or opposition to vaccination, such as:

  • Some people have religious or philosophical objections,
  • Some see mandatory vaccination as interference by the government into what they believe should be a personal choice,
  • Others are concerned about the safety or efficacy of vaccines,
  • Or may believe that vaccine-preventable diseases do not pose a serious health risk.

Several of these could be significant in some geographical areas, within activist groups, community leaders, people with a different mindset, which may not be too difficult to overcome. Whereas, a few others may throw huge financial and logistical challenges to the nations. Interestingly, ‘one in three Americans is reluctant to take a COVID-19 vaccine.’

One in three Americans appears reluctant to be vaccinated:

According to a Gallup poll conducted between July 20, 2020 and August 02, 2020 ‘one in three Americans would not get a COVID-19 vaccine.’ This poll brought out the fact that ‘many Americans appear reluctant to be vaccinated, even if a vaccine were FDA-approved and available to them at no cost. Asked if they would get such a COVID-19 vaccine, 65 percent say they would, but 35 percent would not.’ Moreover, the percentage of Americans who feel strongly that parents should get their children vaccinated has also dropped by 10 percentage points, since 2001.

Other recent polls, reportedly, also found, whereas, around 50 percent of people in the United States are committed to receiving a vaccine, another quarter is still wavering. Some of the communities most at risk from the virus are also the “most leery.” ‘In France, 26 percent said they wouldn’t get a Coronavirus vaccine.’

Which is why, Covid-19 vaccines, which are expected to be available by early 2021, ‘won’t be mandated by the federal government’, according to Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases. “I don’t think you will ever see mandating of a vaccine, particularly for the general public. If someone refuses the vaccine in the general public you cannot force someone to take it,” he opined.  

But how broad is this ‘spectrum of doubt’?

As captured in the article, “The Coronavirus pandemic is the moment of truth for anti-vaccine movement,” published by the Financial Times on April 28, 2020, some of the emerging issues are worth pondering. It wrote, although, there is a small, highly organized group of people who are implacably against vaccinations, ‘there is a whole spectrum of people who are concerned, or are on the fence, about them.’ According to a poll it conducted in late March 2020, Covid-19 ‘outbreak has the potential to change their minds’ in different ways, such as:

  • Just 5 per cent of people in the UK say they would not take a Covid-19 vaccine if it were available, down from 7 per cent the week before.
  • Whereas, in Austria, 18 per cent said they would not take a Covid-19 jab, compared with 16 per cent three weeks previously.
  • The figure is similar in France, where 33 per cent – the highest proportion in the world — disagree with the statement “vaccines are safe”, according to another 2018 survey by the health research organization – the Wellcome Foundation.

Is there any anti-vaccination movement in India?

This issue has been well deliberated in many papers, one such is the article, “Theme – Ethical And Legal Challenges Of Vaccines And Vaccination, Public trust in vaccination: an analytical framework.” It was published in the Indian Journal of Medical Ethics (IJME), Vol 2, No 2 (NS) (2017). It makes some noteworthy points:

  • While vaccination is one of the most successful public health interventions, there has always been a parallel movement against vaccines.
  • Apart from scientific factors, the uptake of vaccinations is influenced by historical, political, socio-cultural and economic factors.
  • In India, the health system is struggling with logistical weaknesses in taking vaccination to the remotest corners; while on the other hand, some people in places where vaccination is available, resist it.
  • Unwillingness to be vaccinated is a growing problem in the developed world. This trend is gradually emerging in several parts of India as well.
  • Other factors, such as heightened awareness of the profit motives of the vaccine industry, conflicts of interest among policymakers, and social, cultural and religious considerations have eroded many people’s trust in vaccination.

The paper concludes by arguing that engaging with communities and having a dialogue about the vaccination policy is an ethical imperative. Be that as it may, the question still remains: With vaccines can people go back to the old normal?

Despite vaccines ‘We cannot go back to the way things were’:

It is for sure now that despite vaccination, people won’t be able to get back to the old normal. On August 21, 2020, the W.H.O further clarified ‘that a vaccine will be a “vital tool” in the global fight against the Coronavirus, but it won’t end the Covid-19 pandemic on its own and there’s no guarantee scientists will find one.’ One can find a clear meaning to this statement, if the same is read along with the W.H.O Chief’s earlier statement that “there’s no silver bullet at the moment and there might never be.”

Other challenges for mass vaccinations in India:

There are some research studies in this area. Let me quote one of those, published in the International Journal of Pharmaceutical Sciences and Research. The paper noted – although, immunization is the most cost-effective intervention for infectious diseases, there exists a scarcity of information on vaccination status of young adults and the role of socioeconomic conditions in India.

The study concluded – although Td/Tdap (97.3 percent) and MMR (66.4 percent) coverage was in line with the recommendations, for all the other vaccines the coverage was lower – varying from 5.5 percent to 35.4 percent. A number of factors were found responsible for limited growth and penetration of vaccines in India, such as:

  • Lack of adequate awareness among both physicians and patients.
  • Patients prefer treating rather than preventing diseases.
  • Vaccines are provided free under UIP program, but only for highly communicable and life-threatening diseases.
  • Obtaining vaccines through private system is expensive and medical insurance policies do not cover vaccines.
  • A lack of quality data on disease burdens and vaccine efficacy is the biggest obstacle in vaccine coverage in India.
  • Distribution is hampered by inadequate cold chains and constrains to last mile distribution. Storage in the clinics is limited due to frequent electricity blackouts in India.

The vaccination coverage was found better in respondents with higher educated and higher income parents. The researchers suggested patient education, planning by government for the implementation of policy for adult vaccination and involvement of physicians are must for better adult vaccination coverage.

Conclusion:

The United States, Brazil and India now account for more than half the total of over 22 million Coronavirus cases, globally. The number of fatalities had also gone past 782,000, as on August 20, 2020.  However, the Coronavirus cases in the country, as recorded in the morning of August 23, 2020, have also reached a staggering figure of 3,044,940 with 56,846 deaths, despite all measures that the country has been taking. No signs of any respite, just yet.

The Government of India has officially acknowledged that for protection from Covid-19 infection, ‘the herd immunity level is “far away” for the Indian population and it can only be achieved through immunization by vaccines.’ Hence, the country’s dependence and stake on this ‘silver bullet’ are very high. From this angle, the vaccine story needs to be viewed from a multifaceted perspective, including what the W.H.O has already cautioned:

  • ‘There’s no silver bullet at the moment and there might never be.”
  • ‘That a vaccine will be a “vital tool” in the global fight against the Coronavirus, but it won’t end the Covid-19 pandemic on its own and there’s no guarantee scientists will find one.’
  • The Coronavirus vaccines alone won’t end pandemic: ‘We cannot go back to the way things were’ in the old normal. In other words, people should try to adapt to the new normal to lead a normal life.

Besides, there could be other problems like, making vaccination mandatory. Or, distributing affordable Covid-19 vaccines through uninterrupted cold-chains in the remotest part of India, and appropriate storage there. Does India have a robust logistics support for the same, in place? Who will pay for all these? And more importantly, are there Plan B, C & D ready, to meet any unforeseen critical situation. Each of these warrants a deep-stick analysis – with a multifaceted perspective, as the devastating impact of Covid-19 pandemic is so real for all, especially for India.

By: Tapan J. Ray  

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.

Unilateral American Action on Agreed Bilateral Issues: Would India Remain Unfazed?

Posted on by
Reply

I discussed in one of my earlier blog posts titled “Has Prime Minister Modi Conceded Ground To America On Patents Over Patients?” of October 6, 2014 that on April 30, 2014, the United States in its report on annual review of the global state of IPR protection and enforcement, named ‘Special 301 report’, classified India as a ‘priority watch list country’.

Special 301 Report and OCR – A brief Background:

According to the Office of USTR, Section 182 of the US Trade Act requires USTR to identify countries that deny adequate and effective protection of IPR or deny fair and equitable market access to US persons who rely on Intellectual Property (IP) protection. The provisions of Section 182 are commonly referred to as the “Special 301” provisions of the US Trade Act.

Those countries that have the ‘most onerous or egregious acts, policies, or practices and whose acts, policies, or practices have the greatest adverse impact (actual or potential) on relevant US products’ are to be identified as Priority Foreign Countries. In addition, USTR has created a “Priority Watch List” and a “Watch List” under Special 301 provisions. Placement of a trading partner on the Priority Watch List or Watch List indicates that particular problems exist in that country with respect to IPR protection, enforcement, or market access for persons relying on IP.

In the 2014 Special 301 Report, USTR placed India on the Priority Watch List and noted that it would conduct an Out of Cycle Review (OCR) of India focusing in particular on assessing progress made in establishing and building effective, meaningful, and constructive engagement with the Government of India on IPR issues of concern.

An OCR is a tool that USTR uses on IPR issues of concern and for heightened engagement with a trading partner to address and remedy such issues.

For the purpose of the OCR of India, USTR had requested written submissions from the public concerning information, views, acts, policies, or practices relevant to evaluating the Government of India’s engagement on IPR issues of concern, in particular those identified in the 2014 Special 301 Report.

The Deadlines for written submissions were as follows:

Friday, October 31, 2014 - Deadline for the public, except foreign governments, to submit written comments.

Friday, November 7, 2014 - Deadline for foreign governments to submit written comments.

India’s earlier response to 2014 Special 301 Report:

On this report, India had responded earlier by saying that the ‘Special 301’ process is nothing but unilateral measures taken by the US to create pressure on countries to increase IPR protection beyond the TRIPS agreement. The Government of India has always maintained that its IPR regime is fully compliant with all international laws.

The issue was raised during PM’s US visit:

According to media reports, Prime Minister Narendra Modi, during his visit to America last month, had faced power packed protests against the drug patent regime in India from both the US drug industry and also the federal government.

The Indo-US joint statement addresses remedial measures:

In view of this concern, Indo-US high-level working group on IP was constituted as a part of the Trade Policy Forum (TPF), which is the principal trade dialogue body between the two countries. TPF has five focus groups: Agriculture, Investment, Innovation and Creativity, Services, and Tariff and Non-Tariff Barriers.

The recent joint statement issued after the talks between Prime Minister Narendra Modi and US President Barack Obama captures the essence of it as follows:

“Agreeing on the need to foster innovation in a manner that promotes economic growth and job creation, the leaders committed to establish an annual high-level Intellectual Property (IP) Working Group with appropriate decision-making and technical-level meetings as part of the TPF.”

Unilateral measures resurface within days after PM’s return from the US:

Almost immediately after Prime Minister Narendra Modi’s return from the US, USTR ‘s fresh offensive with OCR against India’s IP regime, could have an adverse impact on the proposed bilateral dialogue with Washington on this issue.

However, dismissing this unilateral action of America, the Union Commerce Ministry, has reiterated the country’s stand, yet again, as follows:

“As far as we are concerned, all our laws and rules are compliant with our commitments at WTO. A country can’t judge India’s policies using its own yardsticks when there is a multilateral agreement.”

As many would know that several times in the past, India has unambiguously articulated, it may explore the available option of approaching the World Trade Organization (WTO) for the unilateral moves and actions by the US on IPR related issues, as IPR policies require to be discussed in the multilateral forum, such as WTO.

A fresh hurdle in the normalization process:

Many see the latest move of USTR with OCR as a fresh hurdle in the normalization process of a frosty trade and economic relationship between the two countries. More so, when it comes almost immediately after a clear agreement inked between Prime Minister Modi and President Obama in favor of a bilateral engagement on IPR related policies and issues. Let me hasten to add, USTR has now clarified, “The OCR will not revisit India’s designation on the 2014 Priority Watch List.”

What does US want?

The initiatives taken by the USTR, no doubt, are in conformance to the US law, as it requires to identify and prepare a list of trade barriers in the countries with whom the US has trade relations, and with a clear focus on IPR related issues.

Washington based powerful pharmaceutical industry lobby group – PhRMA, which seemingly dominates all MNC pharma associations globally, has reportedly urged the US government to continue to keep its pressure on India, in this matter. According to industry sources, PhRMA has a strong indirect presence and influence in India too.

It is pretty clear now that to resolve all IP related bilateral issues, the United States wants the Indian Patents Act to be amended as an exact replica of what the American lawmakers have enacted in their country, including evergreening of patents and no compulsory licensing unless there is a national disaster or emergency. They require it, irrespective of whatever happens as a result of lack of access to these new drugs for a vast majority of Indian patients.

Thus, it is understandable, why the Indian government is not surrendering to persistent American bullying.

A series of decisions taken by the Union government of India on both patents and drug pricing is a demonstration of its sincere endeavor to increase access to drugs, as less than 15 percent of 1.2 billion people of the country are currently covered by some sort of health insurance.

Global healthcare NGOs strongly reacted:

The Doctors Without Borders’ (MSF) Access Campaign articulated, “India’s production of affordable medicines is a vital life-line for MSF’s medical humanitarian operations and millions of people in the developing countries.”

It further added, “India’s patent law and practices are favorable to public health, were put in place through a democratic legislative process, and are in line with international trade and intellectual property rules… Every country has the right to set policies that balance private business interests with public health needs.”

MSF reportedly warned Prime Minister Modi that US officials and Big Pharma would continue to try to lobby and pressurize him over India’s current patent regime and urged him, “Don’t back down on drug patents”.

“The world can’t afford to see India’s pharmacy shut down by US commercial interests,” MSF reiterated.

Under US bullying, is India developing cold feet?

In the midst of all these, an international media reported:

“Prime Minister Narendra Modi got an earful from both constituents and the US drug industry about India’s approach to drug patents during his first visit to the US last month. Three weeks later, there is evidence the government will take a considered approach to the contested issue.”

Quoting an Indian media report, the above international publication elaborated, the Department of Industrial Policy and Promotion (DIPP) of India, has delayed a decision on whether to grant a Compulsory License (CL) for Bristol-Myers Squibb’s (BMS) leukemia drug Sprycel. DIPP has sent a letter to the Health Ministry, questioning its rationale for saying there was a “national emergency” when chronic myeloid leukemia affects only 0.001% of the population. The letter asked how much the government is spending on the drug, and pointed out that there is no indication of a growing trend in the disease.

This Indian report commented, if the DIPP had agreed to issue a CL for Sprycel on the recommendation of the Union Ministry of Health, it would have ‘cheered’ the public health activists, but would have adversely impacted Indo-US relations that the Indian Prime Minister wants to avoid for business interests.

A Superficial and baseless interpretation:

In my view, the above comments of the Indian media, which was quoted by the international publications, may be construed as not just superficial, but baseless as well.

This is because, DIPP has become cautious on the CL issue not just now, but at least over a couple years from now (please read: Health Min’s compulsory license proposal hits DIPP hurdle, DIPP seeks details on 3 cancer drugs for compulsory licensing).

This is also not the first time that DIPP has sought clarification from the Ministry of Health on this subject.

Hence, in my view, this particular issue is being unnecessarily sensationalized, which has got nothing to do with hard facts and far from being related to the PM’s visit to America.

Conclusion:

The Indian Parliament amended the Patent Act in 2005, keeping the interest of public health right at the center. The Act provides adequate safeguards, including checks on evergreening of patents and broader framework for CL. All these conform to the Doha Declaration, which categorically states “TRIPS Agreement does not and should not prevent WTO members from taking measures to protect public health”.

For similar reasons, the Indian Act does not provide for ‘evergreening’ of patents. The Supreme Court judgment on Glivec is a case in point. If the Indian patent regime is weak and not TRIPS-compliant, the aggrieved country should approach the dispute settlement body of the WTO for necessary action. Thus, it is intriguing if the US, which took India to WTO over the latter’s solar power policy, is not doing the same for pharma IP. Is it really sure that the allegation that ‘the Indian Patent Act is non-TRIPS compliant’ is a robust one?

There is no denying that innovation is the wheel of progress of any nation and needs to be rewarded and protected. However, there is an equally important need to strike the right balance between patent regimes and safeguarding public health interest. In that sense, the Indian Patents Act occupies a position of strength, not weakness.

Considering all these, unilateral American measures against India for amendment of the country’s Patents Act in sync with theirs, ultimately would prove to be foolhardy.

The high-level working group on IP constituted as a part of the bilateral Trade Policy Forum (TPF), would be the right platform to sort out glitches in this arena, keeping Indian patients’ health interests at the center, and at the same time without jeopardizing justifiable business interests of the innovator companies.

Otherwise in all probability, India would continue to hold its justifiable ground on IPR steadfastly, remaining unfazed under pressures and provocations of any kind.

By: Tapan J. Ray

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.

Absence of appropriate and functional ‘Cold Chain’ infrastructure dedicated to pharmaceutical and bio-pharmaceutical products at the Indian airports and seaports – A serious concern

Posted on by
Reply
Drugs are complex entities and many of these are temperature sensitive in nature. This entails them requiring precise and continuous temperature conditions in transit in order to retain their potency and resultant efficacy. Many lifesaving drugs including biotech products and vaccines fall under such category. Any break in the cold chain process for such drugs can lead to immediate denaturing or deterioration in their quality parameters. It is imperative that a careful consideration is given by all concerned including government agencies at the sea port, airports while providing storage space at their warehouses for such drugs.
Current bottlenecks: Currently in India there are bottlenecks at the Airports that include authorities not being able to assure cold room space despite getting advance notices from the companies about the possible unloading of large consignments of temperature sensitive products. Some of the other gaps include improper training and refresher courses for some of the handling staff who handles such products at the Airport. Storage of Pharmaceutical products along with meat and food products is against the GMP norms.

Lack of special temperature control:

Cold Chain Medicines require special temperature controlled Cold storage. There are two commonly recommended temperatures specified on labels on cold chain products:

1. Products requiring temperature between 2 to 8 degree centigrade
2. Products requiring temperature around -10 to -20 degree centigrade

Cold Chain is an uninterrupted series of storage and distribution activities which maintains required temperature range of 2 to 8 degree centigrade or -10 to -20 degree centigrade as per product requirement.

Ensuring the right product quality:

Proper Cold Chain Management of pharmaceuticals will ensure that the right quality of such products is maintained not only during storage but during transportation also to meet right regulatory specifications. There is a greater focus and stringent regulatory guidelines and standards today in the developed markets around the world on strict adherence to right storage and transportation process for cold chain sensitive pharmaceuticals.

It should be kept in mind always that Cold Chain products are mostly sensitive biological substances that can become less effective or lose potency if not properly stored.
Some examples:

Products requiring 2 to 8 degree storage will not be effective if:

i. They are frozen or stored below 2 degree centigrade
ii. Exposed to temperatures above 8 degree centigrade
iii. Exposed to direct sunlight or fluorescent light

The loss of potency is cumulative and irreversible. If products are exposed to conditions outside the established range, the quality may be adversely affected, reducing their assigned shelf life, diminishing their effectiveness or making them ineffective. The exposed product may look the same – the loss of potency may not be visible.

Quality of storage is critical:

Quality of storage and handling of Cold Chain Pharmaceutical products at Airports and Seaports in the course of Export from or Import into India requires special care and attention. Since multiple products are stored and handled at Seaports/ Airports, personnel may not be able to appreciate the special need for Cold Chain Pharmaceuticals Storage & Handling. Thus, there should be Standard Operating Procedures (SOPs) for storage and handling of pharmaceuticals laid down by the Port Management authorities, so that the personnel handling pharmaceuticals strictly adhere to the pre-set norms.

Rapidly growing demand of cold-Chain facilities:

Pharmaceutical Products for which efficient Cold Chain facilities are required are rapidly growing in numbers. In its movement across the supply chain from the manufacturers to the patient, the medicines are handled and stored by various stakeholders like transporters, Airports, Sea ports, Distributors, Stockists, Retailers etc. Since the storage and handling of Cold Chain Pharmaceutical Products are unique, an uninterrupted Cold Chain is to be maintained in the entire supply chain network without any discontinuity, even for a short while, so that medicinal products of high quality reach the patients, always. Thus it is very important for all concerned stakeholders to ensure maintenance of proper Cold Chain facility.

Currently no ‘Pharma Zones’ in India:

At present there are no ‘Pharma Zones’ in India. However, Mumbai International Airport Private Limited (MIAL) has created 4 new cold rooms for pharmaceuticals and Delhi International Airports Limited (DIAL) has reported to have assured that the new Cargo Terminal, which is expected to be commissioned later in the year, will have around 4000 square metres of additional cold room capacity compared to the current cold room capacity of 400 square metres. Similarly, MIAL has agreed for a dedicated Cold Room facility for Pharmaceutical Products in the proposed new set–up.

The serious Concern continues:

Poor cold room storage facility at the country’s major airports and seaports is indeed an ongoing serious concern.

Unfortunately, even today, pharmaceuticals and bio-pharmaceuticals are, by and large, treated like just any other common product at our ports. It is high time, the authorities should note that due to inadequate storage and handling of these lifesaving drugs at ports, high dwell time and dispersed multiple authorities from whom clearances are required, the quality of these products may get adversely affected exposing the user patients at a great risk. The absence of a temperature monitoring mechanism in such facilities adds to the concern.

Recent Plan of “Pharma Zones” in India:

The DCGI has planned a separate dedicated controlled environment – ‘Pharma Zone’, within the cargo premises at Airports and Sea Ports for proper storage of Pharmaceutical products in line with Good Manufacturing Practices and Good Distribution Practices so as to assure the quality, safety and efficacy of Pharma products, which are to be either imported or exported.

Need for outsourcing Cold Chain services:

In the developed markets of the world there are private cold chain storage and third party logistics providers to offer contract logistics and storage services especially to cater to the growing demands Biopharmaceutical segment, which is the fastest growing manufacturing sector within global pharmaceutical industry.

Thus it is expected that spend of the Biopharmaceutical companies towards outsourcing of cold chain facilities will grow by over 10 – 15% for the next three to five years in the developed markets. India being the second largest producers of Biopharmaceuticals after China, similar opportunities exist in the country.

In India some renowned international courier companies like DHL and World Courier have been reported to have developed an efficient cold-chain management process, especially for the pharmaceutical companies to maintain the cold chain in their logistics network.

Conclusion:

An efficient cold chain infrastructure and its efficient management within the country will help immensely to Indian domestic pharmaceutical companies as they are exploring more and more opportunities to export pharmaceuticals in the global market. To achieve this objective modern cold chain warehouses, their efficient management as per regulatory guidelines will play a key role in ensuring right product quality standard.

Over a period of time cold-chain management practices of global standards will be required to achieve this goal. Currently for both import and export of cold-chain sensitive pharmaceuticals, as indicated, before, this area in particular poses to be one of the key challenges encountered by the industry to maintain high product quality during shipment. Individual pharmaceutical companies like Eli Lilly, India have their own vehicles equipped with cold-chain management systems for transportation of their cold chain sensitive products.

Greater initiative by the DCGI in this area in collaboration with the pharmaceutical industry as a whole, sooner, is absolutely essential, for the patients’ sake.

By Tapan Ray

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.

Dire need of quality ‘Cold Chain’ infrastructure for pharmaceuticals in India and its efficient management through Public Private Partnership initiatives.

Posted on by
Reply
Why Cold Chain for pharmaceuticals?Drugs are complex entities and many of these are temperature sensitive in nature. This entails them requiring precise and continuous temperature conditions in transit in order to retain their potency and resultant efficacy.Many life saving drugs including biotech products and vaccines fall under such category. Any break in the cold chain process for such drugs can lead to immediate denaturing or deterioration in their quality parameters. It is imperative that a careful consideration is given by all concerned including government agencies mainly at the seaports and airports while providing storage space at their warehouses for such drugs.

Current bottlenecks and lack of proper cold chain infrastructure:

Currently in India there are bottlenecks at the Airports and Seaports that include authorities not being able to assure cold room space despite getting advance notices from the pharmaceutical companies about the possible unloading of large consignments of temperature sensitive products.

Some of the other gaps include improper training and refresher courses for the handling staff who handle such products at the ports. Storage of Pharmaceutical products along with meat and food products is against the GMP norms.

Cold Chain medicines require different and special temperature control:

Cold Chain Medicines require special temperature controlled Cold storage. There are two commonly recommended temperatures specified on labels of cold chain products:

1. Products requiring temperature between 2 to 8 degree centigrade

2. Products requiring temperature around -10 to -20 degree centigrade

Cold Chain should be an uninterrupted series of storage and distribution activities which will maintain required temperature range of 2 to 8 degree centigrade or -10 to -20 degree centigrade as per products requirements.

Proper Cold Chain Management system is essential to ensure right product quality:

Proper Cold Chain Management of pharmaceuticals will ensure that the right quality of such products is maintained not only during storage but during transportation also to meet regulatory specifications. There is a greater focus and stringent regulatory guidelines/standards are in place today in the developed markets around the world for strict adherence to right storage and transportation process for cold chain sensitive pharmaceuticals.

It should be kept in mind always that Cold Chain products are mostly sensitive biological substances that can become less effective or lose potency if not properly stored.

Some examples:

Products requiring 2 to 8 degree storage will not be effective if:

i. They are frozen or stored below 2 degree centigrade
ii. Exposed to temperatures above 8 degree centigrade
iii. Exposed to direct sunlight or fluorescent light

The loss of potency is cumulative and irreversible. If products are exposed to conditions outside the established range, the quality may be adversely affected, reducing their assigned shelf life, diminishing their effectiveness or making them ineffective. The exposed product may look just as the same – the loss of potency may not be visible.

World class SOPs for Cold Chain storage and handling facilities are essential :

Quality of storage and handling of Cold Chain Pharmaceutical products at Airports and Seaports in the course of export from or import into India requires special care and attention. Since multiple products are stored and handled at Seaports/ Airports, personnel may not be able to appreciate the special need for Cold Chain pharmaceuticals’ storage & handling. Thus, there should be Standard Operating Procedures (SOPs) for storage and handling of pharmaceuticals laid down by the Port Management authorities, so that the personnel handling pharmaceuticals strictly adhere to the pre-set norms.

Pharmaceutical products requiring cold chain facilities are rapidly growing in numbers:

Pharmaceutical Products for which efficient Cold Chain facilities are required are rapidly growing in numbers. In their movement across the supply chain from the manufacturers to the patients, the medicines are handled and stored by various stakeholders like transporters, Airports, Seaports, Distributors, Stockists, Retailers etc. Since the storage and handling of Cold Chain Pharmaceuticals Products are unique, an uninterrupted Cold Chain is to be maintained in the entire supply chain network without any discontinuity, even for a short while. This will ensure that medicinal products of high quality reach the patients, always. it is, therefore, very important for all concerned stakeholders to ensure maintenance of proper Cold Chain facilities.

Government plan of “Pharma Zones” in India:

The Drugs Controller General of India (DCGI) has planned a separate dedicated controlled environment – ‘Pharma Zone’, within the cargo premises at Airports and Seaports for proper storage of Pharmaceutical products in line with Good Manufacturing Practices and Good Distribution Practices so as to assure right quality, safety and efficacy of Pharmaceutical products, which are to be either imported or exported.

Currently no ‘Pharma Zones’ in India:

At present there are no ‘Pharma Zones’ in India. However, Mumbai International Airport Private Limited (MIAL) has created 4 new cold rooms for pharmaceuticals. It has been reported that the new Cargo Terminal of Delhi International Airports Limited (DIAL), which is expected to be commissioned later in the year, will have around 4000 square metres of additional cold room capacity compared to the current cold room capacity of 400 square metres. Similarly, MIAL is also planning for a dedicated Cold Room facility for Pharmaceutical Products in their new set–up.

Need for outsourcing Cold Chain services:

In the developed markets of the world there are private cold chain storage and third party logistics providers to offer contract logistics and storage services especially to cater to the growing demands of the Biopharmaceutical segment, which is now the fastest growing manufacturing sector within global pharmaceutical industry.

It is expected that spend of the Biopharmaceutical companies towards outsourcing of cold chain facilities will grow by over 10% to 15% for the next three to five years in the developed markets. India being the second largest producers of Biopharmaceuticals after China, similar opportunities exist in the country.

In India some renowned international courier companies like DHL and World Courier have been reported to have developed an efficient cold-chain management process, especially for the pharmaceutical companies to properly maintain the cold chain in their logistics network.

Conclusion:

A world class cold chain infrastructure and its efficient management within the country will help immensely to Indian domestic pharmaceutical companies, as well, as they are exploring more and more opportunities to export Biopharmaceuticals in the global market. To achieve this objective modern cold chain warehouses and their efficient management as per regulatory guidelines will play a key role in ensuring right product quality standard that India will export.

Over a period of time cold-chain management practices of global standards will be required to achieve this goal. Currently for both import and export of cold-chain sensitive pharmaceuticals, as indicated above, the available infrastructural facilities pose to be one of the key challenges encountered by the industry to maintain high product quality during shipment and warehousing at the ports. Individual pharmaceutical companies like Eli Lilly, India have their own vehicles equipped with cold-chain management systems for transportation of their cold chain sensitive products.

Greater initiative by the DCGI in particular in this area, in collaboration with the Indian pharmaceutical industry, sooner, is absolutely essential. For the patients’ sake.

By Tapan Ray

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.