The Karnataka State Registered Pharmacists Organisation (KSRPO) sees an imminent need for redrafting the Drugs and Cosmetics Act and Rules. It calls for uniformity in enforcement of the Act and Rules pan-India and has now put forth 13 recommendations to transform the pharma manufacture, cold chain, pharmacies among others in the country to bring in transparency and efficiency into the system.
In this regard, the Organisation has communicated to the Union government to consider its recommendations prior to the redrafting of the D&C Act and Rules. In the area of enforcement of the Act, presently it is partly enforced by the central and state governments. “We see there is a lack of uniformity in enforcement leading to the development of pharma industry in some states only,” said Ashokswamy Heroor, president, KSRPO.
The drugs and cosmetics regulations need to be updated going by the developments in the pharma industry not just in India but globally. The revised D&C Act and Rules need to be made contemporary as India is a recognized hub for high quality competitive manufacturing, he added.
In the area of loan licenses, third party arrangements, manufacturing and marketing, KSRPO claims that there is rampant lending of trade names being resorted to. This, according to Heroor, results in loss of sales for the genuine pharma manufacturers. The result is the flooding of sub-standard, not-of- standard quality, cheap products, and unhygienic preparations in the market. “Therefore we suggest banning of such practices with constant surveillance.”
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Delving on the cold chain infrastructure which is a critical component to the temperature control of sensitive drugs that are distributed across the country, he noted, “There are only a handful of reputed firms going for cold chains in distribution. Our suggestion is to ensure even small scale manufacturers and loan licensees opt for quality cold chain distribution.”
In the area of drug inspection, he said that in several states, the regular checks were found wanting and pointed out that inspections were carried out once in five years, which led to poor assurance to the drug quality.
The Organization calls recruitment of competent technical staff who are only pharmacy graduates and post graduates. The hiring of science graduates has led to large pool of unemployed qualified pharmacists, he said.
Further, KSRPO insists drug inspectors armed with B Pharm should conduct inspection of plants with experts from the pharma chemistry background especially to audit bulk drug units. This is because more often B Pharm drug inspectors were not able to recognize methaqualone, a sedative and hypnotic medication that was manufactured without license.
In the area of Schedule K drugs, Heroor said that it contains a list of drugs which is obsolete and outdated and called for a revision with inclusion of new items.
Herror said that the government should amend retail and wholesale drugs licenses to ensure only qualified pharmacists receive the same. Also Rule 65 (17) should be amended to make full replacement of the expired goods to the chemists. Further, Rule 64 (2) and 62B (2) should be made more specific indicating the ratio between shops and population; number of registered medical practitioners, hospitals in that area or distance between shops, etc. The final point in the recommendations by KSRPO noted that government should not permit e-pharmacy business model in the country.