Without giving any space for any confusion, the Drugs and Cosmetics (Amendment) Bill, 2015 should define the word, medicine, before it is introduced in Parliament. The D&C Act 1940 clearly explains the term, drug, whereas there is no proper definition for the word, ‘medicine’, according to a proposal sent to the director of drugs at the department of health and family welfare concerning amendments.
The Act defines what is drug, whereas it does not distinguish between drug and medicine. The various Acts related to drugs such as the D&C Act, the Pharmacy Act, the Narcotic Drugs and Psychotropic Substances Act, etc do not define the term, medicine. So, it requires a definition with no confusion in meaning, and it may be carried in the amended version of the Act, says Dr KG Revikumar, former professor and head of clinical pharmacy, government medical college, Thiruvananthapuram.
There is a need to explain the word ‘medicine’ as drug is defined as inclusive of all medicines. When a drug is converted into a pharmaceutical dosage form, it becomes a medicine. Likewise, the names, ‘Drug Information Centre’ should be renamed as ‘Medicine Information Centre’, and ‘Essential Drug List' must be rewritten as 'Essential Medicine List', Dr. Revikumar commented.
In a chat with Pharmabiz, he said in olden days the drug, paracetamol, was available in powder form and it was consumed adding sugar. Later, when it was converted into tablet, syrup and injection forms, it became a medicine. The drug, aspirin, was also available in powder form in 1960, later it took tablet form and became a medicine. So, a clear-cut definition for the word, medicine, is necessary and it should be included as a separate paragraph in the draft bill after the definition of drug, he said.
Dr Revikumar’s comments include one significant proposal also. According to him, like the explanation for ‘import’, the Act should define the term, ‘export’ also. In 1940, when the Act was framed, India was importing most of the medicines, not exporting any. Now the country manufactures not only for India, but exports big quantities of medicines to several countries.
Another suggestion was that while amending the title of the Act, the word, ‘manufacture’ should be put in before the word, import. After that one more term, ‘storage’ has to be inserted. In the same way, the word, ‘dispensing’ should also be added in the bill after the term, distribution.
The draft bill describes the title as, “an act to regulate the import, manufacture, distribution and sale of drugs, cosmetics and medical devices, to ensure their safety, efficacy, quality and conduct of clinical trials and for matters connected therewith or incidental thereto”.
Dr Revikumar comments it in the way it should be amended as, “an act to regulate the manufacture, import, storage, distribution, dispensing and sale of drugs, cosmetics and medical devices, to ensure their safety, efficacy, quality and conduct of clinical trials and for matters connected therewith or incidental thereto”.