Regulators & pharmacists demand revocation of Schedule K (5) to make registered pharmacists sole authority to keep & sell medicines

The working pharmacists and regulatory officers across the country are planning to bring a proposal before the Drugs Consultative Committee (DCC) of the Union health ministry to make the registered pharmacists the sole authority to keep and sell medicines in the country. Their demand comes in the wake of the ministry's decision to amend D&C Rules to replace 'chemists & druggists' with 'pharmacy' to give retail trade a better professional recognition.

They want the government to revoke Schedule K (5) in the D&C Act which mandates doctors to stock and 'supply' medicines to their own patients visiting their clinics or hospitals. The term 'supply' should be removed and the word, 'dispensing' should be inserted in the clause by specifying pharmacist's right to handle medicines even in clinics or hospitals run by medical professionals.

In the next DCC meeting, expected to be held in May, the Drugs Controller of Odisha, Mamina Patnaik, will bring a proposal seeking amendment of Schedule K (5)of D&C Act. Speaking to Pharmabiz, Patnaik said Schedule K allows doctors to keep and supply medicines to their own patients. It is not required today as there are more than seven lakhs medical stores in India.

During 1945 and later, there were not much medical shops in the country. So the doctors were given special right to keep and supply medicines to their own patients. Today the situation has changed and we have more than enough medical stores and qualified pharmacists in every nook and corner of the country. In the wake of new amendment of the Rules, the Schedule K in the D&C Act also needs to be amended in order to withdraw the right given to the doctors, Patnaik said. 

S.Lithungo Lotha, Deputy Drugs Controller of Nagaland opined that Schedule K (5) is complicated and creates confusion, so it needs clarification. According to him, Schedule 10 should be removed from the Act and Schedule 13 also needs to be amended.

"There are lots of anomalies in the D&C Rules like the words, 'shop', 'stores'.etc. Chemists and Druggists Association (CDA) was originated from the D&C Rules because of the inscription of chemists and druggists therein. He said while amending the Rules, a clause with 'List of companies and products with authorisation to be submitted', needs to be inserted in the conditions before issuing Form 20 B and 21 B.

Deepak Trehan, president of New Delhi based Pharmacy Graduates Welfare Association (PGWA), commented that there should be strict laws by the government in terms of dispensing of medicines and their handling. No category of professionals except pharmacists should be allowed to keep, sell and dispense medicines. Act needs to be amended in this regard by mandating that deployment of registered pharmacists is necessary not only in the drug stores but in the IP wards of hospitals. Doctors, nurses and clerks should not be allowed to handle medicines.

He further said government should also take steps to include pharmacy services in the Charter of Patients and in the conditions for NABH accreditation.


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