New Pharma Policy: Would Third Party/Contract Manufacturing be Banned?

New Pharma Policy: Would Third Party/Contract Manufacturing be Banned?

As per news circulated through out web, news paper and tv, third party/ contract manufacturing is going to be banned. But we are not sure about source of these news and whether these are true or not. If these are true, then it will not be beneficial for pharmaceutical sector. A large number of manufacturing units and thousands of marketing companies have shut down. This will be great loss to pharmaceutical sector and ultimately medicines will be costlier due to monopoly of few pharmaceutical countries. 

We received queries in this regard from many readers, so we decide to analysis few facts about these news. We will try to find out whether these romours are true or false. Here we are going to discuss about fact which will be change for third party or contract manufacturing. We don’t think, third party or/and contract manufacturing is going to be banned because it is legal phenomena and helpful in growth & new business possibilities. If we study today’s big player in pharmaceutical sector, they started as marketing company. Later they established or overtake manufacturing units. Establishing Marketing Company is much easier than to start a manufacturing unit. If government bans third party/contract manufacturing, then it will effect adversely at pharmaceutical sector growth and will increase unemployment.

Here look at possibilities that would be covered by New Pharma Policy:

In 2006, Draft National Pharmaceutical Policy, Heading Control on Pharmaceutical brands describe a very serious issue. This is what that should have resolved many years ago. This issue was related to brand name resemblance and same brand name for different preparations. For example, We have a Brand Name  Cef for an active ingredient Cefixime and another company is using Cef for an active ingredient Cefpodoxime. Same brand name is using for different active ingredients. 

In second case, Company A and Company B, both are using same Brand Name PAR for paracetamol. This create confusion and lead to misbranding. We have taken a example of only two companies, there are many cases where same brand name is using by number of pharmaceutical companies.  These type of activities have the potential to cause immense harm through mis-prescription and/or wrong dispensing. (We use brand name for sample purpose without checking whether they belong to any company or not. In case these belong to any company, please mail us at for correction)
In India there is no appropriate system to rectify these errors, so it was suggested that “branding of drugs and other therapeutics should be brought under the Central drug regulatory system. The drug regulator must be required to maintain a data base on brands and their compositions, and all brand registration of drugs must compulsorily be approved by the drug regulator. In particular, no change should be permitted in the composition of a given brand. Necessary changes would be made in the Drugs & Cosmetics Act, 1940 in this regard.”

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Few years back, manufacturing companies got approval with Brand Name, Generic Name and Marketed by companies Name from state drug department which was not a desirable practice when marketing is done at the national level. State authorities wasn’t check for brand name already approved/applied within state and/or approved/applied in other states. So, these types of approvals were stopped and approval from generic names were started to manufacturing companies. Once a generic approval was given to a manufacturing company, it was allowed to manufacture any number of brands with single generic approval. It worsen the condition because drug authorities don’t have any control of manufacturing from Brand Names.

 At present present, manufacturing companies get approval by generic name. So drug department don’t have any control at third/contract party manufacturing and brand name fixed by manufacturing and marketing companies. Brand Name registration is at present come under Intellectual property act only and Intellectual property doesn’t cover composition or active ingredients or any technical detail.  Possibility is there government want to regularized third party manufacturing. Draft National pharmaceutical policy, 2006 suggested to transfer brand name approval to central drug regulatory system. But minimum chances of banning third party manufacturing

As per our analysis, it would be compulsory to take brand approval from central drug regulatory by manufacturing or/and marketing company before launching a new product in market other than generic approval by state authorities. Without that no marketing or/and manufacturing company shouldn’t market a product in Indian market. Brand name approval should be compulsory from central drug regulatory whether a manufacturing company has generic approval from state authorities. It will helpful in controlling brand name conflicts as all approvals will be made from single authorities and all records will be maintained. Banning of third party or/and contract manufacturing is not a solution.

One another hot issue of new drug policy is related to labeling of single active ingredient preparations. It is suggested that all single salt preparations should have only generic name, not brand name. Many developing countries have adopted this label pattern along with many developed countries. In India if this implements, it should be welcomed by pharmaceutical industry. If that happens, A single active ingredient will be like a classical preparation in ayurvedic medicines. A well known Ayurvedic Classical Preparation “Ashokarishta”. We find only company logo like Dabar, Zandu, Elzac etc and Name will be same as Ashokarishta. Likewise only Logo in single pharmaceutical active ingredient preparation would be allowed and salt name will be same below logo.

Hope above information is helpful to you…

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