Wrongly labelling drugs under Sch H1 causing confusion to chemists

Concerned over the rising incidence of mislabelling of certain drugs as Schedule H1, pharmacists across the country have urged the regulatory body to urgently look into this matter to clear the confusion among the stakeholders. It was observed by pharmacists that many pharma companies have been wrongly labeling drugs under Schedule H1 category even though they do not fall under the same, creating a lot of skepticism and extra work for the pharmacists.

Schedule H1 which was included in the Drugs & Cosmetics Act after amending the Act in 2013, came into effect from March 1, 2014 consists of a list of only 46 drugs. However, experts point out that there are more products in the market that are being sold under this category than necessary. This they feel needs to be investigated to find out the possibility of any swindling in this matter.

What makes the matter worse for the pharmacists is that under the law, the retailers who are doing manual billing are required to keep separate bill books or separate series of  bill numbers, so that they can produce the records immediately when asked by the drug control officials. With such a long list of medicines it becomes tedious and cumbersome issue for many to keep a record of the drugs, especially when they are well aware that they do not fall under the category.

Need of the hour

The 2012 Patient View survey of 600 international, national and regional patient groups, on the corporate reputation of pharma in general and 29 leading pharma companies in particular showed that the overall industry reputation has dropped. In terms of reputation, the pharma industry was 7th of the 8 healthcare sectors evaluated. Only 34% of respondents gave pharma a “good” or “excellent” rating for reputation. Pharma trailed retail pharmacists (62%), medical device companies (50%), private healthcare services (46%), biotech companies (44%) and generic drug makers (37%).

From a patient’s perspective this negative view of pharma is being driven by:
1)    A lack of fair pricing policies leading to unseemly profits (50%);
2)    A lack of transparency in all corporate activities (48%);
3)    Management of adverse event news (37%);
4)    Acting with integrity (32%)

Till the final quarter of the last century, the pharmaceutical industry's social, political, technological and economic credentials were unparalleled. Its range of noble and altruistic ideals attracted the best and brightest graduates who delivered an outstanding range of new medicines. Its single-minded pursuit of integrity was widely respected and its reputation, image and influence were without equal.

Pharmacists - H1 implementation

In a memorandum recently submitted to the ministry, it brought to the notice of the ministry that pharmacists are facing several practical difficulties due to the ambiguities in the implementation of Schedule H1.

It has been contested that clarity is being sought after on the eligibility of prescribing medicines as it has been observed that homoeopaths, ayurvedic medicine practitioners and allopaths can prescribe medicines in states like Maharashtra.  Since states follow different rule contrary to what has been mandated by the Medical Council of India (MCI) Act, which rule would be applicable and what is the judiciary's perspective on the same is being sought after, as per the memorandum.

The purpose of Schedule H1 has not been understood by the public and that only pharmacists have the onus of maintaining the register is ironical. Besides this, due to the shortage of MBBS doctors in many parts of the country, medical store owners will produce fake bills by putting names of doctors on the bill and rake in profits at the cost of patient safety.

If fake bills are made in the name of physicians, the offenders will have a free hand in evading actions from the state regulatory agencies and Income Tax department. Also, physicians from other systems of medicine can also take advantage of this lacunae and this will encourage quackery.

As per the memorandum, Maharashtra government's drugs department is not able to explain clearly the role of registered medical practitioner in Allopathy, Homoeopathy and Ayurveda streams of medicine. Government of India has formed several administrative units for governing drug trade like the excise department for narcotics and psychotropic substances; department of pharmaceuticals for drugs pricing; Food Licensing authority for food products; health department, Central Drugs Standard Control Organisation (CDSCO) for regulating drug quality and Schedule H1 drugs; and Competition Commission of India (CC) for enforcing healthy competitive practices.

These departments need to be coordinated under the purview of Drugs and Cosmetics Act, 1940. The memorandum seeks clarity whether there is any effort made for coordination of these departments and is it feasible for the retailer to understand and grasp the technicalities involved in understanding various laws governing drug trade of the land.

Chemist - Shops

the Mumbai chemists withdrew the agitation and shops are open without any time restrictions. But most of the chemist shops still do not have a pharmacist at the counter all the time. And the the FDA commissioner has not stopped his state wide inspection of chemist shops to see that pharmacists are present at the retail counter all the time.

Most of state governments in the country have miserably failed to ensure implementation of section 42 of the Pharmacy Act ever since the section was added to the Act. This section came into effect on September 1,1984 to end the practice of running  medical shops without qualified persons. The state pharmacy councils and drug control departments of Andhra Pradesh, Karnataka and Kerala had also conducted similar raids against retail chemists for violation of Section 42 in the past. But the practice continues even today and most of the 6 lakh retail chemist shops in the country are still being managed by salesmen with some superficial knowledge of medicines. Absence of a qualified pharmacist at the counter can definitely affect the quality of service by way of unprofessional counselling leading to wrong dispensing and over medication.

This needs to be strictly curbed in the interest of public health. Section 42 is an ideal piece of legislation and all the developed and most of the developing countries have the practice of keeping full time pharmacists at retail counters. In India, owners of chemist shops are blocking the implementation of the Section from the very beginning. Their objection to have a full time pharmacist at the counter is the 'unbearable' costs of appointing a pharmacist throughout the working hours in a chemist shop. That may or may not be true. But, when anyone venture into a business he cannot bypass the existing laws governing that business. And the enforcement agencies cannot be blind to perpetual violation of the provisions of any Act.


Therefore, both Centre and state governments have to seriously ponder about this lingering issue and have to come out with a right solution without any more delay.