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The Drugs Consultative Committee (DCC) of the Union Health Ministry has recently recommended to the Ministry to amend the Drugs and Cosmetics Rules to issue licenses to pharmaceutical marketers with various conditions to ensure quality and safety of pharmaceutical products marketed in the country. At present there is no provision for monitoring the functions of marketers to ensure quality, safety and efficacy of products marketed in the country. In many cases, the marketer details like address & other details are also not readily available for communication for various regulatory purposes. There are over 30,000 marketing companies operating in the distribution channel of pharmaceutical and cosmetic products in the country. And they do not have any accountability as far as quality of drugs is concerned. Even leading pharma majors known for specific generic formulations access third party manufacturers to produce their drug in particular brand names. In such cases, the common man or patient will be under the impression that it is being actually manufactured by the well-known pharma company. But, in the event of any quality issue, these well-known companies or marketers are nowhere in the picture and only the third-party manufacturers are subjected to punitive actions as per the D&C Rules. There are several loopholes and ambiguities in the Rules which these companies exploit to their advantage. In fact, there is no provision for third-party manufacturing arrangement in D&C Rules. It is illegal and a manipulation of the system which puts small and medium manufacturers in trouble as small companies that are contracted for manufacturing the drugs are the ones liable for quality under the existing law. As per law, there are only three ways to manufacture drugs - own manufacturing licence, repacking licence and loan licence. When anyone wishes to avail the manufacturing facilities owned by a licensee, one is granted a loan licence under Form 25A or 28A subject to the fulfilment of the conditions prescribed under Rules. At the same time, the rules don’t specifically prohibit manufacture of drugs on third party agreements by a licensee or loan licensee, a clause used by major companies and marketers to sign MoUs with smaller firms without any legal obligations.
This scenario should change. It is high time the marketers of the drugs are also made liable and brought under the ambit of law with suitable amendments in D&C Rules. Similar to the manufacturing licenses issued to the manufacturers at present, a separate license should be issued to the marketing companies. It will go a long way in ensuring the quality of drugs available in the domestic market. Separate provisions should be included in the D&C Rules requiring that no marketer shall market any drug without license obtained from the licensing authority. In fact, the industry experts have long been raising the demand for such a move, in order to bring the pharmaceutical marketing firms also responsible for the quality, safety and efficacy of drugs they market in the country. While there are only around 10,500 formulation manufacturing units in the country, a large number of companies are using the facilities through outsourcing and these ‘marketed by’ are not even in the database of the departments or regulatory agencies. While the government has said that the marketing companies who manufacture with another company and market the products in India are responsible for the storage of medicine quality as per earlier notification, there is no provision for monitoring of their functions. Since the manufacturer produces the medicine, and the distribution is by the marketing company to the nook and corner of the country, they should also have the accountability for the product and should also be brought under control.
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