The Central Drug Standards Control Organisation (CDSCO) is planning to frame regulations for non-prescription drugs or over-the-counter (OTC) drugs. In an attempt to curb their sales, the government is also planning to ask chemists to stamp prescriptions so that prescriptions are not reused.
The drug consultative committee (DCC) of CDSCO took this decision to “promote self-care without compromising patient safety, thereby reducing the treatment cost.”
According to this report, the new guidelines will be put in place in a bid to reduce anti-microbial resistance due to overconsumption of such drugs and to fall in line with globally accepted practices.
In the same report, GN Singh, Drug Controller General of India (DCGI), said, “Currently, there can be [a] misuse of high-risk drugs as there are no separate regulations. Names of drugs cannot be sold over the counter are not there. At present, drugs classified as Schedule X, H, H1 G and K cannot be sold without a doctor’s prescription.”
The CDSCO has now decided that OTC drugs will be classified into two categories—OTC-1 and OTC-2—based on the extent of evidence, safety, therapeutic index, need for accessibility to patients, availability, non-habit forming nature, present supply chain mechanism and socioeconomic conditions of the country.