Karnataka State Registered Pharmacists Association (KSRPA) has called for new amendments in the Drugs and Cosmetics (D&C) Act 1940 and additional revisions to D&C Rules 1945.
“These amendments are for the effective day-to-day implementation of the Act and in the interest of the public,” said Ashokswamy Heroor, president, KSRPA.
The Association has made a representation to the Ministry of Chemicals and Fertilizers and the Ministry of Health and Family Welfare to request for new amendments for the D&C Act. It has given a series of recommendation on the required changes.
“In the entire enactment, including the title, the word ‘drugs’ should be replaced by the word “medicines” because it would have a more positive approach. The word drug is seen to have a negative impact.
Definition of ‘Agents’ appearing in section 19(3) of The D& C Act 1940 should be provided in the Section 3. This is essential to obtain convictions against spurious drug suppliers, who take the defence under section 19(3). The law makers have classified ‘agents’, on par with the manufacturer. Thus it is essential to differentiate an ingenious ‘agent’ from an ordinary ignorant gullible dealer.
Therefore Heroor recommends definition for ‘agent’ as a person who receives drugs/cosmetics/medical devices directly from the manufacturer or importer. This amendment will go a long way in controlling the spurious/ adulterated/or not of standard quality drugs/ cosmetics and medical devices, he added.
In section 27(c), in the opening sentence, the word ‘released’ should be replaced with ‘realized’. In section 31(2), provision to confiscate adulterated cosmetics also should be made.
With regards to Section 34AA, jail term may also be prescribed on par with sec.58 (1) of The NDPS Act 1985. In this section, the drugs control officers, who fail to discharge their duties must be made punishable.
In the section 36 AB referring to Special Courts, offences punishable under section 13 and 13A also must be included. The drugs control officers should be empowered to break open a locked premises, on par with the sec42 (1)(b) of The NDPS Act 1985.
Only Coming to Section 36 AC, only some offences have been made cognizable. Instead we are now insisting for all offences to be made cognizable and less severe offences be made bail-able, in order to help quick investigation, pointed out Herror. Further, he has also pressed the government for additional amendments for the D&C Rules 1945.
The Association has called for the deletion of words ‘sale to a hospital, dispensary, medical, educational or research institutions’ included in the definitions of both retail and wholesale, vide Rules 2 (f) and 2(g) should be deleted. Spurious drug peddlers, supply to doctors and go scot free, under this clause. This amendment helps to stop the distribution of spurious drugs and also increases the turnover of the retail chemists. Rules 62(B) and 64(2) needs clear cut norms to grant sale licenses in the rules itself. This will help licensing authorities to exercise power without the fear of accusing of partiality. Uniform enforcement also is possible.
Discussing these issues, Heroor said that these were needed to transform the pharmacy trade, manufacturing and marketing in the country.