Under the Act, prescription drugs fall under two schedulesSchedule H and Schedule X. The latter consists of habit forming, abusable drugs requiring double prescription.
Drugs Controller General of India Ashwini Kumar told FE that a large number of new drugs licensed by the Centre and various state drug controllers as prescription medicines in the last few years have now been formally added to the Schedule H. Apart from Schedules H and X, there is another class of popular drugs reckoned to be household remedies that are listed on Schedule K. Drugs outside these three schedules are considered to be over-the-counter drugs. Multinational drug companies have been pitching for a separate Schedule for OTC drugs for better market access, but the government has decided not to accede to the demand. There is no need for a separate OTC list as drugs outside the prescription drugs automatically have OTC status, Mr Kumar said.
Commonly known drugs like Cetrizine, Omeprazole, etc find a mention in the new Schedule H. The drugs newly added to the list include Tramadol, Cisplastin, Tizanidine, Vinblastin etc. Says a senior ministry official, this revision has been carried out after 1996. A number of new drugs have been introduced in the market since then. It is thus the need of the hour to include them in the Schedule H list in view of patient protection, he said. After inclusion in the Schedule, these drugs will have to follow the requirements of the prescription drug category as specified under the Drugs and Cosmetics Act 1945.
The containers of the preparations containing Schedule H or Schedule X drugs must display the warning: To be sold by retail on the prescription of a registered medical practitioner only conspicuously on their labels.