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Meeting of PCI with State Pharmacy Councils

July 8, 2013 in pharmacist, Pharmacy Council

In order to have better coordination, integration and harmonization between the PCI and SPCs for effective regulation of the practice of pharmacy in the country, a meeting of the PCI with SPCs/Registration Tribunals was held on 15.4.2013.

The various issues discussed during the meeting were -

1· The online Central Registration/Live register.

2· Digitalization of the record by the SPCs.

3· Involvement of the pharmacist in the various National Health Schemes of Govt. of India.

4· Pharmacy professionals entering teaching / industry to register with SPCs.

5· Strict implementation of section 42 of the Pharmacy Act vis-a-vis appointment of inspectors u/s 26A.

6· Fixation of minimum wages for pharmacists.

7· Deletion of obsolete Sections from the Pharmacy Act, 1948.

8· Abolition of Registration Tribunal and constitution of the SPCs.

9· Establishment of Drug Information Centre by the SPCs.

10· NOC by SPCs in time bound manner for transfer / migration of registration.

11· Functioning of SPCs.

12· Creation of separate Directorate of Pharmacy Education in States.

13· Dispensing of medicines by registered persons only in Govt. hospitals/institutions.

14· Registration of Foreign Nationals vis-a-vis admission to Higher Pharmacy Qualification.

15· Uniform fees for registration/renewal/entry of additional qualification.

16· CEP for pharmacists.

The PCI has decided to hold this integration on annual basis to address the various issues concerning registration of pharmacist and practice of profession under the Pharmacy Act

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Effort by Indian Pharmacist Association

June 9, 2013 in association, health ministry, pharmacist, Pharmacy Council

To

Sh. Ghulam Nabi Azad
Hon’ble Union Health Minister
Ministry of Health and Family Welfare
Delhi

Sub.: Violation of Pharmacy Act and Drugs & Cosmetics Act in Hospital Wards – Reg.

Respected Sir,

As per the Pharmacy Act 1948 & Drugs and Cosmetic Act 1940, it has the  provisions that medicines to a patient can be dispensed only by a registered pharmacist on the prescription of a registered medical practitioner. These two acts restrict any other person to dispense medicine including nurses.

According to Section 42 of Pharmacy Act, no person other than a registered pharmacist shall compound, prepare, mix, or dispense any medicine on the prescription of a medical practitioner and whoever contravenes these provisions shall be punishable with imprisonment for a term which may extend to six months, or with fine not exceeding one thousand rupees or with both.

            According to Section 65 Drugs and Cosmetics Rules of Drugs and Cosmetics Act:

            Section 65 (i) Any drug Shall, if compounded or made on the licensee’s premises be compounded or made under the direct and personal supervision of a registered pharmacist.

            Section 65(ii) The supply, otherwise than by way of wholesale dealing, of any drug supplied on the prescription of a registered medical practitioner shall be effected only by or under the personal supervision of a registered pharmacist

 

Sir, I would like to draw to your kind attention that no hospital (pvt. or govt.) have even a single pharmacist posted in a ward.  Medicines in hospitals wards are stored and dispensed by nurses and other staff of hospitals. It is very surprising that work of pharmacist is done by nurses and other hospital staff when there is shortage of nurses and enough availability of registered pharmacists.

A Registered Pharmacist is a qualified person who practices in pharmacy focusing on safe and effective medication use.  He is trained for dispensing and knows every aspect of medicine (i.e. storage condition, drug interaction, side effects, drug-food interaction, bioavailability of medicine etc.).

Therefore, to prevent violation of Drugs and Cosmetics act, and Pharmacy Act and to prevent any error in dispensing pharmacists should be appointed in all govt./pvt. Hospital wards round the clock.

Thanking you,

                                                                                                Yours faithfully

                                                                                                BHUPENDRA KUMAR
                                                                                                General Secretary,IPA

 

Copy to

  1. His Excellency, The President of India, for information with the humble request for immediate necessary action in this regard.
  2. Hon’ble The Prime Minister of India, for information with the humble request for immediate necessary action in this regard.
  3. Hon’ble The Chief Justice of India, for information with the humble request for immediate necessary action in this regard.
  4. Smt. Sonia Gandhi, Chairperson, National Advisory Council, for information with the humble request for immediate necessary action in this regard.
  5. Drug Controller of India, for information with the humble request for immediate necessary action in this regard.
  6. President, Pharmacy Council of India, for information with the humble request for immediate necessary action  in this regard.
  7. Health Minister, All States for information with the humble request for immediate necessary action  in this regard.

 

 

 

BHUPENDRA KUMAR
                                                                                                General Secretary, IPA

 

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FDA lens on drug stock with doctors

March 21, 2013 in DRUGS CONTROL, health ministry, pharmacist, Pharmacy Council

The Food and Drugs Administration (FDA) will inspect stocks of medicines available with doctors from April 1, state FDA commissioner Mahesh Zagade said on Wednesday.

Addressing a state-level conference of principals of pharmacy colleges, he also spoke about the irrational use of antibiotics by doctors and patients.

“The drugs shall be purchased only from a dealer or a licensed manufacturer. Records of such purchases showing the names and quantities of the drugs, together with the batch numbers and names and addresses of the manufacturers, shall be maintained. Such records shall be open to inspection by an inspector appointed under the act, who may, if necessary, make enquiries about the purchase of the drugs. The inspector may also take samples for test,” Zagade said.

According to the Drugs and Cosmetics Act 1940, dispensing and supply of drugs under Schedule K shall be carried out by or under the supervision of a qualified medical practitioner; the premises where drugs are supplied or stocked shall be open to inspection by an inspector appointed under the Drugs and Cosmetics Act who can, if necessary, take samples for test; the drugs shall be stored under proper storage conditions.

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Kerala Pharmacy Council to appoint district level pharmacy inspectors to enforce Pharmacy Act strictly

January 25, 2013 in Pharmacy Council

With a view to enforce Pharmacy Act strictly in the state, the Kerala Pharmacy Council has made a proposal to the government seeking endorsement for Council’s decision to appoint seven more pharmacy inspectors.

Once the government approves the proposal, the total number of pharmacy inspectors under the Council will rise to 14 with one inspector for one district. Currently, one inspector is taking care of two districts to supervise the functioning of pharmacies, said B Rajan, the newly elected president of Kerala Pharmacy Council.

After the constitution of the present Council, a crucial decision was taken in its first sitting that section 42 of Pharmacy Act should be strictly implemented all over the state, for which procedures will be started soon. Without a registered pharmacist, no pharmacy should be allowed to function, whether in hospitals or in community levels. All the pharmacies will be brought under the supervision and monitoring of a pharmacy inspector.

When asked whether supervision of pharmacy inspectors will clash with the inspection of drug inspectors, Rajan said pharmacy council is implementing Pharmacy Act and the drug control department is enforcing Drugs & Cosmetics (D&C) Act.

“We check whether a pharmacy is working under the direct supervision of a registered pharmacist. Further, presence of the pharmacist should always be in the dispensing area. Gradually, section 48 mandating pharmacist in uniform will also be implemented. Each district will have one pharmacy inspector with separate office. Kerala will be the first state in the country to have pharmacy inspectors in all the districts,” he commented.

Another important decision the Council has taken is that it will conduct continuing pharmacy education program for the practising pharmacists both in the government and private sectors. To implement this programme, separate Pharmacy Council Forums will be formed in district wise. The next Council meeting that is scheduled for the 31st of this month will finalize the decision regarding this, he told Pharmabiz.

The Council will publish the draft electoral roll for electing six members to the Council on January 31. The tenure of the elected members was already expired in 2008.

Nominated members other than the president are K M Isahaq, UK Manu, Stanely Daniel and S Ramabhadran. President is also the nominee from Kerala to the Pharmacy Council of India. The new office-bearers of the Council took over charge last month.

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Current Situation of Pharm.D in India.

December 15, 2012 in pharmacist, Pharmacy Council

1) It would be better if the Council makes the CROs and other Clinical/Drug safety related Industries to be aware of Pharm.D and the positions they will be eligible.

2) I have been trying to find an opportunity but some companies says – over qualification but some says – they r looking for MBBS or people with Experience.

3) Pharm.D in India itself is a new course and of course there will be no chance of Experience, then what a Pharm.D can do?

4) In the general public, there are several misunderstandings and even some people are getting confused too.

5) Final thing i would like to mention you is, there is no proper control on Pharma and its career, may be this condition is only for Indian Pharma graduates.

If possible please try to make these things notified by higher authority, WHO CAN BRING SOME CHANGE unless those who listens and says – lets wait, we have other works.

Thank you
Dr. Vijay Bhaskar Reddy K
Pharm.D

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Teaching Staff Who are not registered with State Pharmacy Councils to do so in 1 month

December 14, 2012 in Pharmacy Council

It is requested that the teaching staff who have not yet registered with State Pharmacy Councils, may register with State Pharmacy Councils within one month & fill the same in “Faculty Database” on Council’s website www.pci.nic.in .

All pharmacy faculties shall upload their passport size photograph and pan number.

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Health Min plans steps to get published updated version of Drugs & Cosmetics Rules

October 17, 2012 in DRUGS CONTROL, health ministry, Pharmacy Council

With several amendments to the Drugs & Cosmetics Act and Rules in the past adding to the confusion of the pharmaceutical manufacturers, the Health Ministry is planning to compile all changes and publish a compiled Act.

The Ministry will take up the matter with the publication division to release an updated edition of the D&C Act with rules, following concerns expressed by the industry and other stakeholders who have to scramble through several notifications, published separately, every time to ascertain latest rules.

“Publication of ‘Drugs & Cosmetics Act 1940 & Rules by Government Press has not been done since last so many years. The need of publication is felt as many major amendments have been done in the Act in last few years and  Government Publication is the only authentic book admissible in the courts otherwise so many notifications of the amendments are required to produced in the courts,” sources said.

The Drug Consultative Committee (DCC) also noted the matter recently and made a recommendation to publish the updated version of the Act.

“To overcome these day-to-day problems of collecting old notification the publication of this Act by the Government Press is required so that amended Drugs and Cosmetics Act 1940 & Rules, 1945 can make available to the courts or/other legal persons. Recently Government of India has published the Pharmacopoeia of India & national formulary is in process of publication. The Act should also be published by the concern department,” according to the proposal submitted before the panel.

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Kerala DC officials raid pharmacies selling Sch H drugs without prescription

September 29, 2012 in DRUGS CONTROL, pharmacist, Pharmacy Council

Following a tip off from the intelligence branch of the drugs control department, Kerala, the officials at the ADC office in Kozhikodu conducted surprise raids in several pharmacy stores in Malappuram district and legal action initiated against one store for selling schedule H drugs without prescription.

The pharmacy was found selling anabolic steroids to body building enthusiasts allegedly with the motivation of trainers. The licence of the pharmacy has been cancelled following the raid.

The inspectors have seized illegally sold drugs such as Decabid 25 mg Injection and Nandone 25 mg Injection from Palora Pharmacy at Valancherry. These are included in Schedule H in the Drugs and Cosmetics Act (D&C) and can be sold against prescriptions.

“The retailer was found to be selling these drugs without prescription and without issuing cash/credit bills violating the provisions of the Act. Departmental action has been recommended against the licensee. Both these drugs contain the same chemical nandrolone phenyl propionate (NPP), which closely resembles the male sex hormone testosterone,” said Shaji M Varghese, the intelligence branch inspector at Kozhikodu.

According to him, this drug is usually prescribed to treat osteoporosis in post menopausal women and for weight gain and speedy recovery in severely debilitated patients. In US, it is classified as Schedule III controlled substance under the Anabolic Steroids Control Act 1990 and its illicit possession/ use is a punishable offence.

At Health World at Kottakkal, the officials seized drugs Equigan, Andriol Testocaps and Methane Dienone tablets which were being sold without obtaining licenses. These drugs were stocked in the shop along with specialized nutritional supplements ,for the purpose of sale to body builders. Shaji said the person in charge of the pharmacy has  admitted that requisite licenses under the provisions of D&C Act were not obtained by the shop owner. Here also, the purchase bills pertaining to these drugs were not produced on demand.

The seized products were produced before the Judicial First Class Magistrate court at Malappuram.

The officials said A M Nutrition at Valanchery was selling fortified dietary supplements to body builders. But no stock of drugs was recovered from the shop. When contacted the drugs controller CS Satheesh Kumar, said the seizure of imported anabolics at a pharmacy in Malappuram district shows that there is a network of online pharmacy centered at the district. He said it might be supported by the body building community capable of supplying controlled drugs through clandestine sources.

The raid was conducted simultaneously at Health World, Kottakkal, A M Nutrition and at Palora Pharmacy, Valancherry, led by intelligence branch drugs inspector Shaji M Varghese, drug inspectors A K Raveendran, A HarishKumar, CV Noufal, M Anas and K Keethu.

Source: Pharmabiz

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Pharmacist missing, 27 shops’ licence suspended

September 22, 2012 in pharmacist, Pharmacy Council

The Food and Drug Administration (FDA) has suspended 27 licenses for temporary period after the pharmacist was found missing from the chemist shops. According to rule, a pharmacist has to be at the chemist shop when the shop is open. But during surprise inspection the FDA found 27 shops violating this provision. The licence of these shops have been for suspended to a period ranging between 15 and 30 days.

FDA sources claimed that, the action has been initiated in wake of directive issued by state FDA commissioner. “Earlier, the department was didn’t take any action for these types of violations. Those found repeatedly guilty of such violations were punished with small suspension terms of two-three days,” sources said.

After FDA commissioner discovered that the FDA officers at local level are much lenient and many violators go without proper punishment, he directed every FDA office to take stringent action against such violators. “We have suspended the chemists licenses for 15 to 30 days, where pharmacists were found missing during inspection. Similar assessment of all chemist shops is underway and whoever found guilty of violation would invite strong action,” said assistant commissioner of FDA Chandrapur Sunil Jambhulkar.

Sources claimed that FDA could increase the suspension period up to six months, if these shops don’t fall in line. “The action has scared the retailers. Any suspension for three to six months could lead to expiry of large quantity of drugs in the shop. Moreover wholesalers have become cautious on lending medicines to non-pharmacist retailers,” said a chemist.

Chemist and druggist leader Mukund Dubey however blamed FDA for such violation. “The process of issuing chemist licenses is flawed and full of loopholes. The related law dates back to 1945 and have seen little amendments since then. Time has changed and so there is a need to amend the law as per needs of modern days,” he said.

“Non-qualified people take advantage of loopholes in process and obtain chemists licenses. FDA should make the process infallible, Dubey said. He also lambasted the rising practices of doctors seeking chemist licenses themselves or in the name of their relatives or partners. Of those licenses suspended by FDA, a few are chemists shops run at nursing home or have some connection with doctors.

“FDA is now demanding sale and purchase details of medicines from chemist shops. Why don’t the department ask the same from doctors, who purchase large quantity of medicines, but keep no record of its dispensing? Similarly income tax and sales department should also inquire into this practice of doctors,” Dubey demanded.

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Karnataka State Pharmacy Council

September 1, 2012 in pharmacist, Pharmacy Council

 

Pharmacists are requested to renew their registration certificate before December 2012.

For details visit : http://ipa.medlineindia.com/Microsoft%20Word%20-%20REnewal%20of%20Regn%20_1_.pdf