TIDES IN INDIAN PHARMA

TIDES IN INDIAN PHARMA

BY LEVIN THOMAS, ASST  PROFESSOR,DEPT OF PHARMACY PRACTICE,ACP

1. NDPS Act Amendment bring cheers to Pain and Palliative Care services

The Narcotic Drugs and Psychotropic Substances (“NDPS”) Act has been recently amended through the NDPS (Amendment) Bill 2014, by Indian Parliament. The amendments make important, path breaking changes for medical access to narcotic drugs by removing barriers that date back to 1985, when the Act was first introduced. The amendments also include provisions to improve treatment and care for people dependent on drugs, moving away from abstinence oriented services to treating drug dependence as a chronic, yet manageable condition. India is one of the leading producers of morphine, yet patients in the country could not access it owing to the stringent licensing requirements under the NDPS Act and Rules 1985 framed by State Governments. Statistics reveal that the medical use of morphine declined by 97% after the NDPS Act came into force.

This will now change as Parliament has adopted a new category of “essential narcotic drugs” in section 2 (VIIIa) of the Act – a list, which the Central Government can notify on the basis of expediency in medical practice. Drugs identified as essential will be subject to Central Rules under section 9(1)(a), which will apply uniformly throughout the country, bringing to an end the unwieldy and inept practice of obtaining multiple State licenses for possession, transport, purchase, sale, distribution, use and consumption. Currently five essential narcotic drugs (END) — morphine, codeine, ethyl morphine, oxy-codone, hydro-codone and fentanyl and the salts of all these drugs will now be made available to registered medical institutions on a single licence issued by the state drug controller's office.

Now all states will have to create a single licence system with the state drug controller empowered to issue it. This amendment has been a game changer for medicines meant for palliative care and pain management. However, for this to be a success, the government has to amend certain laws to make a distinction between illicit drug traffickers and legitimate entities for using the narcotic drugs.

2. Red Alert on e-pharmacies in India

From electronic gadgets to trendy cloths and baby-food, it’s all available online. But the sale of medicines over the internet in India over the recent times has split the retail pharmaceutical world wide open. The medical fraternity has raised a huge red-flag of caution who warn that it could open the door for greater misuse of cough syrups, painkillers, narcotics and antibiotics. There are no proper regulatory parameters for e-pharmacies in India at present. As a result illegal and unregulated online sales of prescribed medicines in India have increased a lot. This fact also came to the knowledge of Indian government and now online pharmacies websites of India are under regulatory scanner and punishment may follow.

Individuals and companies selling pharmaceutical products through website are required to comply with various laws. These include laws related to medicines and pharmacy profession, e-commerce and cyber law of India. The Drugs and Cosmetics Act, 1940, and the Drugs and Cosmetics Rules, 1945, have clear guidelines on the sale of Schedule H and Schedule X drugs. These can be sold only on prescription and there are specific rules, including for labelling. Surprisingly most of the online pharmacies stores and websites in India are not aware about the cyber law. As a result they are violating the provisions of Information Technology Act, 2000. In April, the Telangana Drug Control Administration stopped online portals under Medplus, Apollo and Bookmeds Medicals from selling medicines in contravention of the Drugs and Cosmetics Act (1940), according to media reports. “The staff of DCA, appearing as customers, ordered Schedule H and H1 drugs (restricted drugs) without the prescription of a registered medical practitioner online and through telephone and the online pharmacies delivered the same,” a report in The Hindu said. Despite Snapdeal getting a rap recently from the Maharashtra Food and Drug Administration for selling medicines online – several aspirants are waiting in the wings, ready to roll-out their online models of e-pharmacies.

In the absence of clear cut policies and guidance, e-pharmacies in India is facing legal roadblocks. The legal enablement of e-pharmacies in India is urgently required. In the UK and US, regulators caution consumers to buy only from registered sites and not be lured by discounts or medicine shipment without prescription. In United States, the Health Insurance Portability And Accountability Act Of 1996 and Health Information Technology for Economic and Clinical Health Act (HITECH Act), etc are some of the laws that take care of medico legal and techno legal issues of e-health and telemedicine. Laws like these are missing in India. There is also a gross deficiency of data protection and privacy laws in India. Thus, private data and health records can be leaked by these online pharmacies with little grievance redressal and compensation mechanism. It is high time for Indian government to regulate illegal and unethical online pharmacies operating in India and frame suitable law on matters concerning them.

3. New Drugs Approved in India

Sl.No.	Drugs	Indications
1	Levocetirizine ODS 2.5/5mg (Additional dosage form)	For allergic rhinitis and chronic urticaria
2	Decitabine Injection 30 mg/vial (Additional pack size)	For treatment of patients with myelodysplastic syndromes (MDS)
3	Meloxicam ODT 7.5/15 mg (Additional dosage form)	As Non-steroidal anti-inflammatory
4	Ruxolitinib Tablet 5/15/20 mg (Additional indication)	Treatment of patients with polycythemia vera who are resistant to or intolerant of hydroxyurea.
5	Gadopentetic acid dimeglumine salt injection 469mg/1ml (0.5mmol) (Additional indication)	For use in MRI in adult patients to facilitate visualization of lesions with abnormal vascularity in the body (excluding heart)
6	Pazopanib Tablet 200/400mg (Additional indication)	For the treatment of patients with advanced Soft Tissue Sarcoma (STS) who have received prior chemotherapy
7	Eribulin mesylate solution for injection 0.88mg in 2ml vial (Add. Indication)	For the treatment of patients with locally advanced or metastatic breast cancer
8	Abiraterone acetate Tablet 250 mg (Additional Indication)	For the treatment of metastatic castration resistant prostate cancer in adult men