WHAT IS EXPORT AN PACK?
India has a very vibrant and fast growing local pharmaceutical industry. India's pharmaceuticals exports in 2008 were almost $9 billion where Indian pharmaceutical companies exported products to almost 120 countries worldwide. Indian pharmaceutical industry has become one of the lowest cost and high quality producer of generics medications. If anyone wants to import pharmaceuticals into their country their first choice will be an Indian pharmaceutical company.
Currently Indian pharmaceutical companies export products to USA, EU, South East Asia, Middle East and Africa. When a product is exported into another country the final appearance of the product depends a lot on the local FDA or equivalent authority of that country. For example, USA has the most stringent requirements for a product that can be sold in the US. This does not mean that the product being sold in other countries is any less effective. It is just that US FDA has certain testing and labeling requirements that a pharmaceutical company has to comply with after receiving permission to sell in that particular country.
Why are labeling requirements important?
Every country has a different standard of labeling every product. This is the only way a consumer in the country can understand more about the product and in case of any problems take some recourse around it. The US has a specific set of product labeling requirements, Canadian requirements are different, European requirements are different and Indian requirements are different. So if a pharmaceutical company wants to sell the same product in these different countries the packaging label must meet the different standards of that country.
What are the standard labeling requirements in pharmaceuticals?
There are some requirements which are quite standardized, meaning almost every sensible country will surely ask for this information on the pharmaceutical pack
Requirement |
Why is it required? |
|
|
Name of generic product |
To see what molecule is inside the product |
Name of local brand |
If the product is sold under a particular name then this brand name comes above the generic name; these names differ from country to country |
Location and address of manufacturing |
Very important as this is the only way you as a consumer can know at which manufacturing facility of the pharmaceutical company was the product manufactured |
Batch No. |
Information of the specific batch |
Manufacturing date |
Date of birth of the product |
Expiry date |
Date after which the product should not be consumed |
Leaflet |
Information pack inside the outer box which explains the pharmacology and chemical information about the product |
These are the standard packaging requirements in most cases. Many countries may ask for more information but less information on the pack is a rarity.
Do all countries ask for the above-mentioned details to be mentioned on the pack?
All developed countries require that the above mentioned information be present at the minimum on the product label and outer box. Most developing nations like India, Malaysia,Thailand also ask for the above information on the product packaging and the outer box. Majority of the less developed countries like Nigeria and Ethiopia also require similar labeling requirement.
However there are some countries that do not have specific packaging and labeling requirements. These countries are Afghanistan, Iraq, Mozambique, Egypt, Sudan, Tanazania, Uganda, Zambia, Zimbabwe and a few more African nations. These countries do not insist that the manufacturer mention the location of manufacturing on the product pack. So while the site of manufacturing is available in product registration documents it is not required to be mentioned on the packaging and label.
What difference does this make to me?
This is the tricky part. There are many well-known large pharmaceutical companies in India that make and sell products in these African nations. It would be naive to assume that a pharmaceutical company makes the product meant for USA and for Africa in the same manufacturing facility. Pharmaceutical companies make products destined for African nations at a different plant and in many cases get it made under contract with another manufacturer.
Unfortunately these products, meant for African nations could be ending up at your doorstep. How you ask? A pharmaceutical company will sell product to a trader for sale in a particular country or zone. It has no control over the product once it leaves it warehouse. Most of the times these traders have allied with Canadian mail order and internet pharmacies, diverted the products meant for sale in Africa to a filling center in Asia or the Pacific Island and then are getting dispensed to you the US consumer.
In such a case the pharmaceutical company is not even aware that its products meant for Africa is ending up at the household of an American consumer. It is the traders who are misrepresenting this fact and take advantage of this misinformation. The result is that while you will be assuming that you are buying a product from Cipla that is available in India, this is not the case. You are actually buying a product that Cipla made for the African market (not even the Indian market), assuming that it is made for India.
How do I get to know from the export pack about the manufacturers name and location?
There are only 2 ways to do this. One, you insist with your regular pharmacy that you only want to buy India product which has the manufacturing location mentioned on it. Two you only buy product that is made for sale in India.
What must Iook for in the packaging and label when I buy international products?
You need to ensure that any product you buy has the following information clearly and legibly written on it:
- Brand name or local name under which the product sells in that country
- Generic or chemical name of the product
- Product dosage strength
- List of ingredients
- Name of Manufacturer
- Location of manufacturing facility including country
- Batch number
- Manufacturing Date
- Expiry Date
- MRP or Maximum Retail Price along with the actual price; this is the price at which the consumer buys the product in that country
These are the labeling requirements for a product sold in India. We feel you should not accept any less information on the product pack. If people living in India require it so should you as Americans
What products does BuckADayPharmacy.com sell?
At BuckADayPharmacy.com we only sell products that are made for sale in India. We do not sell any export pack destined for another country which is then diverted for sale in USA. With us you buy the same product that more than 1 billion people living in India are consuming.
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