Indian pharmaceuticals companies are controlled via different bodies during different stages of drug discovery, manufacturing and selling. Indian Drug and Cosmetics act of 1940 gives teeth to central government regulate and supervise the industry. Via this act, the pharma industry is governed under central and state bodies for different stages.
Before a new drug to enter market, the manufacturing company has to first take marketing clearance from DCGI (Drug Controller General of India). DCGI, will give in principal approval after looking at clinical trials, drugs efficacy data. After getting this marketing approval, company is free to manufacture and sell its drugs anywhere in India.
Then come the role of state agencies, which take care of the issues related to give permission and clearance for the manufacturing facility, this is after the company has decided a state to set up a new facility or using existing facility to manufacture new drug. Also, once a drug is in market for 4 years, any other company can copy it and will not require to move to DCGI to take marketing permission and will straight away move to state authorities to take manufacturing permission.
Once, manufacturing has started than there is a role of state and central drug inspectors who on regular basis pick random sample of medicines from the market and send them to labs for testing. Once, the tests are conducted and if a sample comes under “Not of suitable Quality”, the drug inspector sends this report to the relevant state authority (where the drug was manufactured) for them to take further action.
There is also a proactive mechanism for companies to ensure that there medicines are of best quality and companies themselves start picking samples from the market to test them for quality standards and do voluntary recall whenever relevant. But India has not seen any such voluntary recall of a batch of medicine by any of the companies.
Given there are 36 different states and UTs in country and 1 central regulator. There are total of 37 different regulators working independently of each other. There is no prescribed rule and operating procedure under which this regulators are organised, trained and resourced. Andhra, for example has an IPS officer at the help for the state drug regulator. This makes a clear case for necessity for a central regulator which can monitor and regulate all manufacturing and marketing value chain of a pharmaceutical company.
There is also a requirement of alert and drug recall system. Before a company goes into investigation it is critical to spread the information of any spurious drug in the medical fraternity as well as immediately recall entire batch of a given drug from the market. As of now central regulator has thrown this responsibility to state government. There is a structural defect in case it is managed by state level authorities. First and foremost is transferring of drugs from one state to other to try to sell them till the time its possible. Lack of coordination between different state bodies to identify and alert relevant stakeholders.
There is a flaw in which central officials are reprimanded due to lapse of following proper processes. There are instances when multiple drugs were incorrectly given marketing access in India without a proper check on fitment an clinical trials report. Even after a sou moto case of carelessness, health ministry did not set up any enquiry or punish person concerned.
Establishment of pan India database which captures atleast last 5 years of NSQ drugs details with manufacturer. This will help medical fraternity and patients to take a conscious call when in doubt.
Indian regulation via schedule M has included GMP (Good Manufacturing Practices written by WHO and are consistent across world) in the law. GMP lays down the data gathering, data storage of manufacturing in certain format for certain time frame. Also, it instructs to manufacture, store and package medicines in sterile environment. Post Ranbaxy debacle, US FDA has stepped up investigations in all pharma manufacturing facilities and still has not got conviction that these companies are following best manufacturing practices. Indian companies for Indian production has been regularly flouting GMP bringing Indian patients at stake of poor health despite spending so much money. It took a foreign authority to figure out poor manufacturing processes, whereas state investigation authorities are still conducting investigations into the matter and companies are freely manufacturing and selling drugs from these facilities at health risk of domestic users.
There is also a circular published by DCGI instructing all Indian pharma companies of sharing information with DCGI of any fine or notice or ban imposed by foreign regulators to asses its impact on Indian patients. But neither DCGI or state regulators has taken a note on this or inquired companies of sharing this information.
Unlike western countries where even after innovator drug has moved past its patent period, the generic drug manufacturer has to conduct studies (this include the rate at which drug is dissolved in human bloodstream) to show that there output is bioequivalent of what innovator drug company is producing. Companies also have to establish that drugs will have potent API till medicine does not hit its expiry period. But in India after 4 years of new drug status, a generic manufacturer has no responsibility to conduct such trials before launching medicine. Ministry has taken this decision citing it will impact the profitability of the industry.
There has also been discrepancy in punishment given by different state authorities in case of poor manufacturing processes. This happens because central government has not published standardized punishment measure towards companies.
There is a very high rejection rate of average 25% by Indian army and Indian railway when they are procuring generic drugs from small manufacturers. Despite such high rejection rate there is no process through which loop is closed and manufacturer is penalised.