Central Drugs Standards Control Organisation (CDSCO) is working towards drafting a new Drugs & Cosmetics Act, 2016 and a Medical Devices Act, 2016. The move follows after the ministry of health and family welfare initiated steps to revisit the D&C Act 1940 and Rules 1945. The effort is to match up with the current regulatory requirements related to safety, efficacy and quality of drugs and medical devices.
The government has taken a decision to remain updated to newer technology and with the onset of several revised guidelines that have come in not just from global regulatory authorities but also India. Moreover, for the government, pharmaceuticals is a priority sector and therefore it has found it critical to ensure that its regulations are required to be strengthened.
Going by the new developments spanning from online pharmacy, fixed dose combinations to medical devices manufacture needs revision the existing D&C Act & Rules and the effort to draft the D&C Act, 2016 and rules are being updated. In fact, a notice has been issued by director (Admin) of CDSCO on June 6 to all state drugs controllers requesting to give feedback based on their experience within 15 days from the said notice. There have been several transformations like new brands, biologicals and biotech drugs besides the fixed dose combinations that need a set of dedicated rules.
The US FDA audits reported data integrity which has resulted in a slew of warning letters and suspension orders on production for poor documentation. The Drugs and Cosmetics Act & Rules 2016 will also ensure complete compliance by the Indian pharma industry.
There is also the introduction of Central Licensing Authority (CLA) along with State Licensing Authority (SLA) and Central Licensing Approval Authority (CLAA) for Schedule III drugs in the last year's Amendment Bill.
The new regulations may also cover the Uniform Code for Pharma Marketing, Formation of Task Force to formulate bulk drug policy, medical devices policy, creation of price monitoring and resource units in the state drugs control department.
With active pharmaceutical ingredients (APIs) being the core of any drug formulation, the government has seen the need to come out with a bulk drug policy and therefore the new Drugs and Cosmetics Act 2016 may see appropriate related inclusions.
In an age of information technology and with the advent of e-commerce, online pharmacy is the way forward. With several companies already in this line of business, the government has called for fresh set of guidelines to be imposed for this business model to keep violations at bay by forming a committee under the chairmanship of Maharashtra FDA Commissioner and yet it has to submit its recommendations in this regard.
With Prime Minister Narendra Modi’s slew of programmes like the Make in India and importance of indigenous manufacture of medical device is being promoted. This may call for dedicated chapter in the D&C Act, 2016 with rules for monitoring and manufacturing unless separate Act and rules are framed for regulation of medical devices.
For the pharmacy trade, penalty clauses are likely to be included. It would make certain that industry and trade will not be able to exploit and embark on unfair practices.