INDIAN PHARMACIST ASSOCIATION

Following the judgments from the Kerala High Court and later on from the Supreme Court of India in favour of the drugs control department of Kerala in the SLPs filed by the Kerala branch of the Qualified Private Medical Practitioners Association (QPMPA), the drugs control sleuths of Haryana last week raided two major private hospital pharmacies in Panchkula and seized huge quantum of medicines for not obtaining pharmacy licence from the department.

The officials registered cases against National Skin Hospital and Alchemist Hospital for violation of sections 18a and 18c of the Drugs & Cosmetics Act. Lalith Goyal, the drugs controller of Haryana said the drug store house of one of the hospitals was also working without licence.

This is the first incident of cases against hospital pharmacies for selling drugs without licence in a state outside of Kerala after the Supreme Court dismissed the SLP (C), No 6877/11 on 18.3.2011 filed by the QPMPA, an association of doctors running private hospitals.

With regard to the reported departmental action by Haryana drugs control department, Dr Kishore Kumar, the secretary of the QPMPA said the drug control officials have no right to raid the pharmacies of hospitals because it is the right to a doctor to keep drugs in his place of work. According to him the doctors’ community is exempted from drug licence under section 5 of Schedule K of the D&C Act, and it is a constitutional right enjoyed by them for the last 70 years. He said the drug authorities have misinterpreted Section 5 A in Schedule K to impose drug licence on all hospital pharmacies and thereby to bring the hospitals under their control.

After losing the case in the supreme court, and before that 21 years of fight in the high court of Kerala, the QPMPA informed the President of India Pratibha Patil and the Chief Justice of India that due to the ignorance of the bureaucracy one clause in item 5 of Schedule K in the D&C Act 1940 and Rules 1945 is misinterpreted and it needs amendment. Following it, the Central Drugs Standard Control Organisation (CDSCO) invited the QPMPA office-bearers for a detailed discussion and interpretation of the clause in item 5 of the Schedule K of the Drugs & Cosmetics Act (D&C Act).

The Kerala High Court in its order of March 25, 2010 had mandated all pharmacies attached to private hospitals in Kerala, either for dispensing or for stocking drugs, to obtain licences from the drugs control department. Against this verdict, the QPMPA filed a review petition in the high court which was dismissed later. After that, the doctors association approached the Supreme Court which also did not give them a relief.

In Kerala, the drug control officials went one step ahead in enforcing the Act properly by strictly insisting the wholesalers not to supply medicines to the hospital pharmacies which have no licences. Ten wholesale dealers’ licences were cancelled by the department for not following the orders of the department.

But the doctors’ body got a severe setback from the high court while dismissing their petition. The Court ordered the Association to make a payment of Rs..10,000 as legal cost to the Kerala Legal Services Authority.

Source: Pharmabiz

Soruce: Pharmabiz

In a major crack down on pharmacies for operating without registered pharmacists, the Andhra Pradesh Drug Control Administration (AP DCA) conducted raids on the retail and corporate pharmacies in the state and booked as many as 281 cases against the medical shops spread across the state.

In the raid, it has been found by the AP DCA officials that more than 70 per cent of the pharmacies in the state are operating without registered pharmacists and do not issue regular bills to consumers.

The raids were conducted by DCA as a part of its special drive to check the functioning of registered pharmacists in the state. The drug inspectors and other DCA officials found various irregularities by many medical stores and issued notices to them especially with regard to the absence of the registered pharmacists and for selling outdated drugs at the stores.

Corporate pharmacies like Apollo, Hetero Pharmacy, Medimart and Medplus were also raided.

When contacted a DCA official said, “We have conducted the raids as per the Drugs and Cosmetics Act, 1940 (DCA), the Drugs and Cosmetics Rules, 1945 (DCR). Many pharmacies are not complying with the rules and acts as mentioned while issuing the license.” Based on the complaints, the DCA has acted on the pharma stores and brought to light many irregularities.

About 406 retail medical shops throughout the state were raided  and out of these 281 retail medical shops were found selling medicines in the absence of registered pharmacists and without bills.

All the licensing authorities and assistant directors were directed to issue show-cause notices to the violators and appropriate action following the notices would be taken by the licensing authorities.

“We have noticed that registered pharmacists were not available at many retail pharmacies. So, the DCA inspected over 406 retail medical shops, including retail outlets of corporate pharmacies. Out of these, 281 medical shops were found selling medicines without pharmacists or without bill,” Said  R P Thakur, director general of DCA, Andhra Pradesh.

“We have even found that some expired drugs are being sold without bills and we have checked all these aspects while raiding the shops,” Thakur said.

“In addition to issuing show-cause notices, the shops will be closed for one week. If the same violation is repeated, we will cancel their license,” he said.

Source: Pharmabiz

The Andhra Pradesh Pharmacy Council has launched a campaign against registered pharmacists who hire out their certificates to other unqualified persons for running medical stores. The council is planning to recruit Pharmacy inspectors in the state to check the illegal renting of certificates.

“Over the past 30 years, lending of certificates has become a regular practice by the pharmacists. More than 90 per cent drug stores are violating the norms of recruiting a qualified pharmacist for dispensing the drugs. Instead they are hiring certificates from registered pharmacists and employing unqualified people at the stores. To check this menace, we are planning to recruit 26 new pharmacy inspectors by the end of this year. These inspectors will have the authority to check and inspect the medical shops for any misrepresentation,” said Annappareddy Vijayabhasker Reddy, president, AP Pharmacy Council.

According to 1948 Pharmacy Act 26 (A), lending or impersonating certificate is a crime and if found guilty it will amount to a punishment of 6 months imprisonment along with a fine of Rs.1000. The council even has the right to derecognize the certificate.

To speed up the registration process and bring accountability in the council’s activities, the newly elected president is also planning to atomize the registration process. “We want to shun the old practice of issuing certificates manually, rather we want to computerize all the processes and make it online for the convenience of the candidates. We want to digitize all the earlier data and store it in a master server. This will enable us to retrieve and verify any query easily in future,” said Reddy.

For this academic year, the council is planning to complete all the registrations by the end of January 2012. So far, 71,000 pharmacists have been registered in the state, another 50,000 pharmacists have not got registered due to the issues related to non recognition of institutes. Next year it is estimated that about 72,000 pharmacists will get registered as the profession is slowly getting its recognition.

During the past 6 months, the council could generate a revenue of Rs.70 lakh by increasing the registration fee from Rs.500 to Rs.5000. “During the past 30 years, the state council could generate only Rs.2 crore of revenue, while other states like Maharashtra and Kerala have generated Rs.22 crore and 11 crore respectively. We are far behind them. Now, as we want to modernize and provide much better services we need money and thus we have increased the registration fee,” Reddy said.

Source: Pharmabiz

The Union health ministry will soon withdraw its ban on advertisements on emergency contraceptive pills like Unwanted-72, Option-72 and I-Pill. The ministry had imposed the ban in January last year after experts raised concern that these advertisements may promote the misuse of the pill by the young generation.

According to sources, the Drugs Technical Advisory Board (DTAB) of the union health ministry in its meeting held on October 10 has decided to allow the advertisements on  emergency contraceptive pills with some riders. As per the new DTAB guidelines, a committee consisting of the principal of a reputed girls college, representatives from civil society groups and the advertising council should screen the ads and the scripts before they are on air.

Ever since the drug companies launched advertisements on emergency contraceptive pills like Unwanted-72, Option-72 and I-Pill, experts and public interest groups in the country have been raising concern that these advertisements may promote the misuse of the pill by the young generation who have started looking at the pills as a regular contraceptive method as the advertisements are said to have failed to drive home the message clearly that these pills are emergency contraceptives.

Apart from the civil society organisations, gynaecologists in the country have also been expressing concern on the misuse of the pill by the young generation. It triggered a debate in sexually conservative India with critics arguing that the easy availability of such pills would encourage promiscuity among the millions of young people. There was also criticism that the easy availability of these drugs will also promote unsafe sex among younger generation and may result in promotion of diseases like HIV/AIDS in the country.

When the public criticism reached its crescendo after the companies started airing competitive ads on these pills, the Drugs Controller General of India (DCGI) banned the advertisements on these emergency pills and left the matter to the DTAB, which is the highest authority of health experts on technical matters under the union health ministry.

Now that the DTAB has taken a final decision in favour of the pharma companies, they can start advertisements on these pills.

Source: Pharmabiz

The Drug Controller General of India (DCGI) has asked the state licensing authorities not to grant fresh licenses or renewals of the combination products of paracetamol, containing more than 325 mg per tablet or capsule.

The DCGI, in a notice to the zonal and sub-zonal officers of Central Drugs Standard Control Organisation (CDSCO), asked them to covey it to the respective State authorities. “The manufacturers marketing combination products having more than 325 mg of paracetamol should be asked to limit the paracetamol contents to 325 mg only in a period of three years,” it said.

The manufacturers of paracetamol combination products may also be asked to provide box warning on the label of such FDCs indicating that ‘taking more than daily dose may cause serious liver damage or allergic reactions such as swelling of the face, mouth and throat, difficulty in breathing, itching or rash,’ according to the order.

The order was issued based on the decision of the Drug Technical Advisory Board (DTAB) which agreed that as the paracetamol is known to have liver toxicity in the light of the decision taken by the US FDA, India also should limit the content of paracetamol to not more than 325 mg per tablet or capsule in the combination products in a phased manner in three years.

The proposal of limiting acetaminophen (paracetamol) was considered by the DTAB in the wake of US FDA issuing a note in January last year. The US agency asked the manufacturers of prescription combination products in USA to limit the amount of acetaminophen to 325 mg per table, citing the toxicity complications and with a view to ensuring patients safety.

The US FDA had also mentioned in the note that there was no immediate danger to patients who take these combination pain medications and they should continue to take them as directed by the healthcare providers. “The risk of liver injury primarily occurs when patients take multiple products containing acetaminophen at one time and exceed the current maximum dose of 4000 mg within 24 hours. The elimination of higher dose prescription combination acetaminophen products will be phased out in three years and would not create shortage of pain medication,” according to the US FDA note.

Source: Pharmabiz

The Central Drugs Standard Control Organisation (CDSCO) has invited the Qualified Private Medical Practitioners Association for a detailed discussion and interpretation of the clause in item 5 of the Schedule K of the Drugs & Cosmetics Act (D&C Act). This follows a letter sent by the Association to the president of India on this matter.

Desperate after losing a case in the supreme court after 21 years of fight in the high court of Kerala, the QPMPA, Kerala Branch in a letter to the President Pratibha Devi Singh Patil, mentioned that due to the ignorance of the bureaucracy one clause in item 5 of Schedule K in the D&C Act 1940 and Rules 1945 is misinterpreted and needs amendment.

The Act does not demand private hospitals to obtain drug licences to run their pharmacies attached with them. But, the drug control officials in Kerala insisted the doctors to take licences for their pharmacies. Since the Act is written in English language, perplexity persists in the meaning of one sentence which is being used as a weapon by the drug control authorities to pester the private hospital establishments under the pretext of drug licence, the letter alleged.

The doctors association has requested the president of India to initiate corrective measures to save the D&C Act and Rules without being misinterpreted by certain regulatory officials. According to them, section 6.3 of Medical Ethics does not permit doctors run or open drug shops.

The CDSCO in a letter to the QPMPA has asked them to submit all the letters the association had sent to the President’s office and to other constitutional bodies, and the copies of their monthly journal. Dr K Kishore Kumar, secretary of the QPMPA had sent letters to, besides President of India, the Chief Justice of India and to the chairman, National Human Rights Commission.

In the letters to the constitutional bodies, the secretary said even the advocates who were engaged by him to argue the case also did not properly grasp the inherent meaning of the clause, hence he could not win the case. So the confusion over the meaning of the clause has to be avoided through an amendment with correct language.

According to Dr Kishore Kumar, after the dismissal of the SLP (C), No 6877/11 on 18.3.2011 by the supreme court , the drug control department has given wide publicity and forced all the private hospitals in Kerala to take drug licences.

The Kerala High Court in its order of March 25, 2010 had mandated all pharmacies attached to private hospitals in Kerala, either for dispensing or for stocking drugs, to obtain licences from the drugs control department. Against this verdict, the QPMPA filed a review petition in the high court which was dismissed later. After that, the doctors association approached the Supreme Court which also did not give them a relief.

Since all the doors are closed before the QPMPA, it has, at last, approached the supreme head of India with a request to rewrite the Act itself.

Source: Pharmabiz

Putting an end to almost two weeks of administrative vacuum in the  drugs control general of India (DCGI) office, the Madras High Court has granted a three-month extension to Dr Surinder Singh to continue as the DCGI. As per the judgement pronounced today, Dr Singh has to demit office on October 31, 2011.

By vacating the interim stay order that the court issued on July 20, it further ordered the Union government to expedite the process of recruiting a new person for the post of DCGI within three months of receipt of this order. Dr Singh cannot continue beyond three months of the court order.

The first Bench comprising chief justice M Y Iqbal and Justice T S Sivanjaanam delivered the judgment of the court taking note of the submission and assurance given by Additional Solicitor General of India, Mohan Parasaran, who appeared on behalf of the government. The ASGI, on Monday had informed the court that government would speed up the process of recruiting a new DCGI.

The Union health ministry has already given advertisement for the recruitment of new DCGI.

The Government of India had on June 8, 2011 extended the appointment of Dr Surinder Singh as DCGI until 31. 3. 2012. The DCGI’s deputation tenure was to expire on June 21, this year.

The public interest litigation (WP 15607/2011) against the appointment of DCGI and the extension was filed by T K Ramalingasamy, a former regulatory officer of the Tamil Nadu Drugs Control Department. Advocate P T Asha from Sarvbhouman Associates,  appeared on behalf of the petitioner.

Source: Pharmabiz

In a scathing attack on Pharmacy Council of India (PCI) for its disapproval notice given against the six months course being conducted by the Academy of Pharmacy Management and Guidance (APMG), Kolkata, the secretary of the academy said their course is different from the courses offered by PCI, hence they don’t want any recognition from the statutory body.

The academy was floated by West Bengal Unit of the All India Chemists and Distributors Federation (AICDF) to train the unqualified pharmacists in the state. The traders associated with the academy demand for amendment in the Drugs & Cosmetics Act, 1940 in respect of dispensing of drugs from retail shops.

Coming down heavily on the decision of the pharmacy council, the traders argue that they are getting packed formulations from manufacturing companies and handing over the drugs against valid prescriptions. They neither make any drugs nor add anything into the formulations, then why should they appoint qualified pharmacists in their drugs stores. Instead, they will train their pharmacy workers updating with latest developments and knowledge about new drugs.

In response to the letter sent by PCI to the Academy stating disapproval of its six months course, Drug Store Management Course, the Secretary of the Academy, Joydeep Sarkar has commented that he did not want any recognition from the PCI or from West Bengal Pharmacy Council to run their course as it is not meant for registration. The course is meant only to upgrade the knowledge of the pharmacy workers, especially D-category pharmacists who are in plenty in most of the rural areas of the state.

“Our course is compact, tailor-made and pharmacy-friendly. It is aimed to the practical knowledge of those who are engaged in the drug stores without sufficient qualifications. We are updating with the latest developments happening in the pharmaceutical sector, especially knowledge about new drugs. This is not for registering with any council or for any higher study. We are giving training to our workers,” he said.

He said the Diploma and the Degree courses approved by the PCI are in many ways inadequate and  insufficient  to run a chemist shop conveniently. The D Pharm course consisting two years study and 500 intern hours is much below than the International standard of contemporary studies conducted in foreign countries. This PCI approved courses do not include much of the regular practical training and knowledge about drugs and pharmacy in the entire curriculum, which are the obligatory part in pharmacy management and operation, he said while accusing the statutory body for disapproving his 6 months course.

He said it is a pity that PCI instead of taking steps to avoid the shortage of registered pharmacists for the chemists shops in the country, bringing stringent norms just to make the healthcare services complicated. APMG is trying to follow WHO‘s guidelines to arrange proportionate health workers for the ailing community even in the remote, rural areas where government health support is very poor. The Academy believes that it is no way unconstitutional to learn more for improving skills and services while the pharmacy workers are engaging in essential and specialty products. The Academy is very keen to educate and update the experienced pharmacy workers to reduce the probabilities of minimum mistakes from any chemist shop while serving or dealing with the patients, the secretary of the academy told Pharmabiz.

“APMG has never published any newsletter or circular or notes demanding their DSM Course as an alternative to the D-Pharm or B-Pharm course. We subsequently demand amendments in the Drugs & Cosmetics Act, 1940 to eradicate the ambiguity and confusing facts in respect of dispensing of drugs,” he added.

Academy of Pharmacy Management & Guidance has already arranged constructive meetings with the ministers and MLAs of west Bengal on this burning issue and is hopeful that a favourable decision from the government will come out soon. According to him the academy will open more study centres of DSM Course in other districts shortly.

Source: Pharmabiz

The Madras high court has ordered that the two-year extension of service granted to Drug Controller General of India (DCGI) Surinder Singhremain stayed till further orders. A notification announcing the extension was issued on June 8, 2011.

A public interest litigation (PIL) filed by Ramalingasamy, retired joint director of drugs control, Government of Tamil Nadu, asked for a “competent person” to be appointed to the post and transfer the official holding the position at present back to his parent department.

The petition held that the selection of Surinder Singh is being questioned as his appointment “can be of detriment not just to the drug industry but also the general public.”

It listed out initiatives undertaken by the DCGI that were questionable such as giving manufacturing permission to pharma companies for emergency contraceptive pills (levo norgestrel products) and allowing their over-the-counter sale. The petitioner added that a case is pending in this regard before the Andhra Pradesh High Court.

The petitioner also added that the DCGI has not taken any remedial action on the hauls of expired drugs and “has not even called upon State Drug Controllers to discuss the issue.” The matter is likely to come up for further hearing in 10 days.

Source: The Times of India