DoP endorses KSRPAs suggestions to amend DnC Act and DPCO

Bengaluru, November 22, 2021:

The Department of Pharmaceuticals (DoP) has now accepted the Karnataka State Registered Pharmacists Association (KSRPA)’s suggestions related to amendment of the Drugs & Cosmetics Act & Rules and the Drug Price Control Order (DPCO) and would incorporate the same during the revision of the regulations.

These are related to removal of loopholes and bring in accountability for pharmacy trade and manufacturers.

The department has communicated the same to the KSRPA.

In early September, KSRPA had pointed out the anomalies to the Acts with reference to Para 2 related to the maximum retail price which reads like an incomplete sentence. Under Para 2(u) on New drugs, the definition differs from the one used in para 32(iii) explanation. Both should be made one and the same.

Under Para [2(zd)], the definition of wholesaler has to be rewritten so as to restrict its meaning as a seller who sells only to a retailer. Selling to hospital, dispensary, medical or educational or research institution or any other agency needs to be deleted from the definition. These categories of buyers are consumers or patients who are on many occasions facing the challenge of high prices, said KSRPA.

“It is not the intention of this order to help them make money at the cost of the poor retailers’ margin of profit. The accepted legal route of supply chain is from the manufacturer or Importer to the wholesaler or distributor via the retailer and to end consumer or patient. It is unlawful to permit any one in this chain to bypass the other, deprive pharmacy retailer of his justifiable livelihood”, pointed out Ashokswamy Heroor, president, KSRPA in his communication to the DoP.

Referring to the Calculation Method of the ceiling prices in para 4 and 6, Heroor categorically pointed out that it was unscientific. On the face of it, it appears as evolved to help some greedy manufacturers but not the consumers. The fixing high prices is based on the aggregate of the existing inflated prices. The prices fixed by this method cannot be fair pricing. This process is ineffective to control the profiteering by companies.

Noting that the method of calculation in para 7 of the DPCO 1995 was quite scientific, the KSRPA president said that the same method has to be followed in this order also. The pharmacy trade market is flooded with free goods and bonus offfers.

Providing examples, Heroor said: “Amitax 500 injection amikacin sulphate injection IP by Alkem Ulticare Company offers 1+1 free. Cardiforce injection Dobutamin 250 by Torrent Pharmaceuticals is 7+8 free. Thrombiflo 60 injection enoxaparin sodium again by Torrent Pharmaceuticals is 1+1 Free …. etc. These offers are an illegal practice, resorted to by suspicious manufacturers. This unlawful move encourages the dilution in the standards of quality, cheating in volumes, circulation of spurious and substandard drugs, and cut-throat competition among other malpractices. Moreover, the likelihood of extending such offers for spurious drugs other than the manufacturers cannot be ruled out. The government is also bound to lose considerable revenue like excise duty,sales tax, VAT, Income Tax etc. in the long run”.

Taking cognizance of the loopholes in the Drugs & Cosmetics Act & Rules and the Drug Price Control Order, the Department of Pharmaceuticals immediately communicated to KSRPA that its suggestions will be incorporated during the amendment process. Pharmabiz