India Medications and the World

India Pharma Manufacturers and the World

Who regulates Indian pharmaceutical manufacturers? Are all of them the same?

India has a very vibrant local pharmaceutical industry. The local market is growing at almost 10% per annum. The value of all pharmaceuticals produced and sold in 2009 was almost $20 billion. Half of this was for local consumption and the other half was export. It is estimated that by 2020 the Indian pharmaceutical market will be worth $50 billion. It will rank 3rd largest in worldwide sales after USA and Japan. India will not only become 3rd largest consumer of pharmaceutical in the world, it will also become the largest exporter of pharmaceutical worldwide.

As can be expected any business that is growing so fast and so big has all kinds of companies operating in the business. At last count India has more than 25,000 manufacturing facilities. The Drug Controller General of India (DCGI) is the apex nodal authority for all pharmaceutical manufacturers in the country. It is akin to the US FDA. All standards, improvements, approvals etc are given by the DCGI. As it is the federal authority it regulates the industry but cannot effectively implement the regulation. That part is left to the state Food and Drug Administrations (FDA). The state FDA has to ensure compliance and has physical oversight over manufacturing standards and practices.

The Indian pharmaceutical manufacturers can be roughly divided into 3 categories: the big boys, the mid sized players and the small-scale businesses.

The big pharmaceutical companies are large sized pharmaceutical manufacturers having annual revenue in excess of $200 million. All these companies have multiple manufacturing facilities. They would also have at least one of their facilities complying with international manufacturing standards (European MEA or US FDA).

Currently there are 37 companies that have internationl regulatory approval. At last count 125 manufacturing facilities in India had US FDA approval. India has the largest number of US FDA approved facilities outside of USA. However it is these 37 companies which have all these approvals. The top companies, which have US FDA approvals, are:

• Ranbaxy
• Cipla
• Sun Pharmaceutical
• Dr. Reddy's Laboratories
• Wockhardt
• Lupin
• Cadila
• IPCA
• JB Chemicals
• ZydusCadila
• Glenmark Pharmaceutical
• Nicholas Piramal

These companies are bound to have a high manufacturing standard as some of their manufacturing facilities are audited by Indian DCGI and US FDA. As a user and consumer I don't deviate much from the above companies when I am buying a product for personal consumption in India. There are a few more companies (37) but most of these are contract manufacturers and so do not sell their products in the open market under their own name but make it for someone else.

The next category of companies is the mid sized players. These are companies are between $10 and $200 million of revenue. There are about 500 companies, which belong to this list. They would total to around 1200-1500 manufacturing facilities. These companies are large sellers with their main focus being the local Indian market. Their export sales would not be more than 25% of revenue and so its likely that they have just 1 facility approved by international agencies. None of these companies have US FDA approval. They are regulated by the state FDA and Indian DCGI and have high quality and standards for sale in India.

The 3rd category, small-scale manufacturers is the soft underbelly of Indian pharmaceutical manufacturing industry. There are more than 20,000 manufacturing facilities that belong to this category. More than 90% of these have sales less than $1 million per annum. Their manufacturing standard is suspect and the state FDA is unable to physically regulate them due to the sheer numbers. What has also happened is that a lot of these small manufacturers are making generic product for Canadian internet pharmacies and are selling it as India generic. As a consumer I would never ever buy products from these companies are their quality and manufacturing standard is suspect.

As with any product you as a consumer also need to be careful when you are buying product from India. It is always the small players who give the industry a bad name. When you are buying from your pharmacy check name of the manufacturer of the product is. Insist on a name from your pharmacy. Accepting an answer like its India generic is not good enough. As you have read there are almost 25,000 manufacturers, and all of them do not have the same standards. Ask for the name and check against the above mentioned names. If the pharmacy cannot provide these manufacturers then you need to be cautious.

Once you get your package once again check the name of the manufacturer against the name that you had asked for. Do not accept any other product made by a different manufacturer. If there is no manufacturing name and manufacturing address on the product pack, and on the strip do not accept the product. Remember, as per Indian law every manufacturer must print their name, site of manufacturing, manufacturing date, expiry date and maximum retail price on the outer box and on the blister. If any one of these is missing please be careful, the product may not be what your ordered for.

Keep in mind 9 out of 10 times, like in buying anything else, you will not go wrong. To ensure that you save yourself from the 1 out of 10 times you must do proper diligence on who you are buying from and what you are buying.

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