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

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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.

65% of Indians do not have access to affordable modern medical treatment – why?

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India is indeed a country of many paradoxes. Not just peaceful co-existence of luxurious sky scrapers and dilapidated shanties side by side. In the healthcare sector as well, we witness on one side booming medical tourism of foreign nationals to get various types of ailments treated with the best possible medical amenities, just when on the other side common diseases like, malaria and tuberculosis are taking the common man on a rampage. Is India, therefore, ignoring the crying need to strike a balance between extending cost competitive healthcare benefits to the ‘haves’ of the world without neglecting the domestic ‘have nots’?Another paradox, when India caters significantly to the growing needs of the world for low cost generic medicines, 65% of Indian population cannot afford the same and do not have access even to a doctor.In a situation like this, what sort of equitable distribution of healthcare benefits are we then talking about? Isolated attempts of opening low cost generic medicine shops, enforcing rigorous non-transparent price control, attempt to divert the debate on the price of patented medicines which contribute miniscule decimal points on the total pharma market in India, can at best be termed as populist measures, instead of trying to look at the macro picture to address the pressing healthcare issues of the country.

When we talk about affordability, why do we not talk about affordability of medical treatment as a whole and not just affordability of medicine, for one or many ailments that the common man suffers from? Will our government try to address this bigger issue in a holistic way?

What could possibly be the reasons for such inaction? Is it because improper co-ordination, if not lack of co-ordination, between various Government departments, the ultimate victim of which is the common man?

Such a situation reminds me of an old story of three blind men and an elephant. After touching the trunk of the elephant, one blind man describes the elephant as a large Python, touching a leg of the elephant, the other blind man describes it as a pillar. The third blind man while touching the body of the elephant describes it as a strong wall. Unfortunately no one could describe the elephant as it really is and no one in this particular case was helping them to do so, either.

Could it be that various departments of our Governments are acting like these blind men and are not seeing the big picture – the elephant of the above story? It appears that the Pharmaceutical department of the Ministry of Chemicals and Fertilizers believes that only the price of medicines is the key issue for an ailing patient while going for a medical treatment and not the cost of total treatment. Thus, they seem to be working full time to drive down only the price of medicines.

The Ministry of Health is also trying to do a little bit of something in some not so known areas. The Ministry possibly believes that they are effectively helping everybody to address the pressing healthcare issues. It does not so appear that the Ministry realizes that majority of our population does not have access to affordable modern treatment for the ailments that they are suffering from. Number of doctors, nurses, hospital beds etc. per 1000 of Indian population is still abysmally low even compared to some developing nations. Cost of getting a disease diagnosed even before any medicine is prescribed is sky rocketing, at a break neck speed. Which Government department is trying to address the cost of disease burden and trying to alleviate it for all of us, in a holistic way?

Here comes another paradox. While the Pharmaceutical Department intends to bring down the price to make the drug affordable, the Finance Ministry keeps the transaction cost of medicines at a high level by levying various taxes to improve its revenue collection, ultimately making the same medicine less affordable.

In the developed nations and also in many emerging markets healthcare financing or health insurance for all strata of the society is being successfully implemented to address the key issue of improving access to affordable modern treatment to a vast majority of the population. Even after 61 years of independence we have not been able to address this critical healthcare financing issue effectively.

Piece meal approach of our Government has not succeeded much to address this important issue of the country. Taking one-off populist measures of various types and creating media hype may not help sorting out this issue, at all.

The way forward, very broadly speaking, is to bring the entire healthcare policy making and implementation functions under one ministry. If that is not possible, the concerned ministries should work in unison, with effective procedural interfaces being put in place for proper co-ordination with a clear goal of improving access to affordable modern treatment to all.

Is it not a shame on us that even today, 65% of Indian population does not have access to affordable modern medical treatment?

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.